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    [title] => Cardinal Health's Cordis Expands Interventional Cardiology Portfolio with Radial Offering
    [short_title] => 
    [summary] => This launch marks the beginning of a global radial product portfolio rollout to reach cardiovascular patients worldwide.
    [slug] => cardinal-healths-cordis-expands-interventional-cardiology-portfolio-with-radial-offering
    [body] => Cordis, a Cardinal Health company, recently announced the full U.S. launch of its RADIAL 360 portfolio, offering a complete range of products to facilitate the transradial approach (TRA) for interventional cardiology procedures.
 
The transradial approach uses the radial artery in the wrist to access the body's arterial system, instead of using the femoral artery in the groin. This launch marks the beginning of a global radial product portfolio rollout to reach cardiovascular patients worldwide. The Cordis RADIAL 360 portfolio is composed of:
   
Compared to a femoral access approach, TRA in the wrist can offer fewer bleeding complications, faster post-procedure mobility, improved patient comfort, and faster patient discharge resulting in reduced in-hospital costs.1,2,3 TRA use in the U.S. is currently estimated to be approximately 30 percent of overall percutaneous coronary interventions and growing.4 In ST-Segment Elevation Myocardial Infarction (STEMI) patients alone, which represent the most severe type of heart attack, TRA use increased from 2 percent in 2009 to 23 percent in 2015.5 In Europe, Japan, China and Canada, TRA is currently used in the majority of cases.6,7
 
"The transradial approach has been an important advancement in how we treat coronary artery disease because of both the patient benefits, and the advantages realized by the hospital in terms of procedure flow and economics," said Kintur Sanghvi, M.D., FACC, FSCAI, associate medical director of Interventional Cardiology at Deborah Heart & Lung Center in Browns Mills, NJ and inventor of the RAILWAY System. "We look to the industry to help us advance the tools available for this technique, which Cordis has done with the introduction of the RADIAL 360 portfolio. In my experience with the RAILWAY System, I see the clear advantage of downsizing the radial access by up to 2 French, a benefit that I'm unable to achieve with anything else that's currently on the market."
 
In addition to the RAILWAY System, which received CE Mark in March 2017 and was FDA cleared in April 2018, the portfolio features the RAIN Sheath Transradial Introducer, which offers an ultra-low profile design, lubricious hydrophilic coating, and proprietary KINK RECOVERY TECHNOLOGY that enables the sheath to maintain lumen patency throughout the procedure, even after a kink occurs.
 
"It's really exciting to have new and innovative tools to support complex radial revascularization procedures for our patients. These improvements in sheath and catheter technologies will enable us to increase radial adoption in the U.S. so that we can maximize PCI success while minimizing bleeding complications," said Dr. Kevin Croce, MD, PhD, director of the Chronic Total Occlusion Complex Percutaneous Coronary Intervention Program at Brigham and Women's Hospital in Boston, Mass.
 
In addition, the RBL-TG and RBL-JK Universal Shapes build on the strong legacy of Cordis catheter technology, and the ZEPHYR Band is designed to simplify how a physician closes the procedure.
 
"The RADIAL 360 portfolio is another important advancement in how Cordis is re-shaping the interventional cardiology landscape," said Patrick Holt, president, Cordis. "Coupling the RADIAL 360 launch with our global portfolio of interventional cardiology products including guidewires, guiding and diagnostic catheters, balloons, stents and closure devices, further marks our commitment to bringing innovative solutions to patients worldwide who suffer from cardiovascular disease."
 
Cordis will showcase the RADIAL 360 portfolio at SCAI 2019 in Las Vegas.

References
1 Romagnoli E, Biondi-Zoccai G, Sciahbasi A, Politi L, Rigattieri S, Pendenza G, Summaria F, Patrizi R, Borghi A, Di Russo C, Moretti C, Agostoni P, Loschiavo P, Lioy E, Sheiban I, Sangiorgi G. Radial Versus Femoral Randomized Investigation in ST-Segment Elevation Acute Coronary Syndrome: The RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-Elevation Acute Coronary Syndrome) Study. Journal of the American College of Cardiology Volume 60, Issue 24, 18 December 2012.
2 Mauricio G. Cohen and E. Magnus Ohman. Should the Benefit of Transradial Access Still Be Questioned? Journal of the American College of Cardiology: Cardiovascular Interventions. Volume 9, Issue 9, May 2016.
3 Amit P. Amin et al. Costs Associated with Access Site and Same-Day Discharge Among Medicare Beneficiaries Undergoing Percutaneous Coronary Intervention. Journal of the American College of Cardiology: Cardiovascular Interventions. Volume 10, Issue 4, February 2017.
4 Data from the American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR).
5 Javier A. Valle, Lisa A. Kaltenbach, Steven M. Bradley, Robert W. Yeh, Sunil V. Rao, Hitinder S. Gurm, Ehrin J. Armstrong, John C. Messenger and Stephen W. Waldo. Variation in the Adoption of Transradial Access for ST-Segment Elevation Myocardial Infarction Insights from the NCDR CathPCI Registry. JACC: Cardiovascular Interventions. November 2017.
6 Zheng X, Curtis JP, Hu S, Wang Y, Yang Y, Masoudi FA, Spertus JA, Li X, Li J, Dharmarajan K, Downing NS, Krumholz HM, Jiang L; China PEACE Collaborative Group. Coronary Catheterization and Percutaneous Coronary Intervention in China: 10-Year Results From China PEACE-Retrospective CathPCI Study. JAMA Intern Med. 2016 Apr; 176(4): 512–521.
7 Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, Frasier D, Gulati R, Skelding K, Bertrand O, Patel T. Transradial arterial access for coronary and peripheral procedures: Executive summary by the transradial committee of the SCAI*. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):823-39. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-05-14 14:32:00 [updated_at] => 2019-05-14 14:36:09 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["303180","306276","313428","304362","310104","309278","307350","313719","313349","312954","312814","312374","311673","311491","311395","311006","310992"] [is_show_company_name] => [created_at] => 2019-05-14 14:26:39 [contentType] => ContentType Object ( [className] => ContentType [content] => Array ( ) [taxonomy] => Array ( ) [listURL] => [logoUrl] => https: [id] => 2487 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => content_types [tag] => breaking_news [short_tag] => breaking_news [class_name] => [display_view] => [list_view] => [slug] => breaking-news [box_view] => [ignore_flag] => 0 [image_id] => 0 [layout_id] => 0 [formattedTag] => Breaking News ) [viewURL] => /contents/view_breaking-news/2019-05-14/cardinal-healths-cordis-expands-interventional-cardiology-portfolio-with-radial-offering/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303180 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Cardinal Health","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178748 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => FDA Approves Cardinal Health's INCRAFT AAA Stent Graft System [short_title] => [summary] => The flexible endovascular aneurysm repair system treats infrarenal abdominal aortic aneurysms. [slug] => fda-approves-cardinal-healths-incraft-aaa-stent-graft-system [body] => Cordis, a Cardinal Health company announced that the U.S. Food and Drug Administration (FDA) has approved its INCRAFT AAA Stent Graft System for use in complex access anatomies. The INCRAFT system is an ultra-low profile and flexible endovascular aneurysm repair (EVAR) system designed to treat infrarenal abdominal aortic aneurysms (AAA).
 
The INCRAFT system was given a favorable recommendation on June 12 by a Circulatory System Devices Panel of the Medical Devices Advisory Committee, following a review of clinical data from the pivotal INSPIRATION trial, a prospective, multi-center, single-arm study designed to evaluate the safety and effectiveness of the INCRAFT system in patients with AAA. The trial showed that the INCRAFT system met the primary safety and effectiveness endpoints, with a low rate of major adverse events at 30 days, high rates of successful aneurysm treatment and survival, and no aneurysm ruptures through four years of follow up.
 
“We welcome the recent FDA approval of the INCRAFT stent graft system which offers U.S. physicians a treatment option for patients with AAAs who otherwise might not be suitable for other EVAR devices,” said Dr. Michel Makaroun, M.D., Professor and Chair of vascular surgery at the University of Pittsburgh Medical Center, and Co-Principal Investigator of the INSPIRATION study. “While EVAR systems have advanced rapidly over the years, there still remains a need for a low-profile EVAR device that is designed to be easy to deliver in complex access anatomies while facilitating precise placement.”
 
“INCRAFT is an attractive new ultra-low profile EVAR option that allows for bilateral in-situ adjustment during the procedure, helping to minimize the need for additional components or extensions,” said Dr. Takao Ohki, Chairman and Professor of Surgery and Chief of Vascular Surgery at the Jikei University School of Medicine in Tokyo, Japan and Co-Principal Investigator of the INSPIRATION study.
 
While several EVAR devices are currently available in the U.S., treatment options are limited for many AAA patients with small femoral or iliac arteries or with heavily calcified or tortuous vessels that could lead to complications during the introduction of EVAR devices.
 
“We are excited to announce INCRAFT FDA approval, which will enable high-risk AAA patients in the U.S. to benefit from more than a decade of investment in R&D and clinical research,” said Patrick Holt, president of Cordis at Cardinal Health. “Cordis continues to invest in expanding our product offering to meet our global customers’ needs, whether via innovations like our Mynx Control Vascular Closure Device and our RADIAL 360 portfolio, or via strategic alliances, which brought the EluNIR drug-eluting coronary stent to the U.S.”
 
The INCRAFT system, which received a CE (Conformité Européenne) mark in 2014, is commercially available in many global geographies, including Canada and countries in the European Union, the Middle East, South America, and Asia Pacific. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-29 11:04:00 [updated_at] => 2018-11-29 11:08:34 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289765","289756","290022","289745","282690","289790","289757","302111","299797","284487","302836","299288","302016","282688","300250","302305","283697","302922","282390","296562","282544","282670"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304362 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179653 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Intact Vascular Hires Industry Veteran as Vice President of Sales [short_title] => [summary] => Prior to joining Intact Vascular, new hire was the vice president of U.S. sales for Neuronetics. [slug] => intact-vascular-hires-industry-veteran-as-vice-president-of-sales [body] => Intact Vascular Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, announced that Steve MacKinnon has joined its senior management team as vice president of Sales, effective immediately. Reporting to the CEO, MacKinnon will oversee the creation of a U.S. based sales team and will play a central role in planning and executing the company’s projected launch of the Tack Endovascular System in 2019.
 
“Steve brings a stellar track record of sales achievement across a broad range of entrepreneurial medical technology companies,” said Bruce Shook, Intact Vascular’s president and CEO. “Steve’s experience with creating and motivating high performance sales teams, coupled with his deep knowledge of the peripheral vascular market, will be tremendous assets to us as we move toward launch of our flagship product next year.”
 
Prior to joining Intact Vascular, MacKinnon was the vice president of U.S. Sales for Neuronetics, where he significantly expanded the sales team and product revenue, and helped take the company public. Prior to Neuronetics, Steve served as vice president of U.S. Sales for Access Closure and was instrumental in its successful merger with Cardinal Health. He also held multiple sales positions with Fox Hollow Technologies prior to its sale to eV3.
 
“Intact Vascular represents an exciting opportunity to bring high-value innovations to peripheral vascular patients,” said Steve MacKinnon. “I look forward to building a world class sales organization at Intact and to a very successful launch of the Tack Endovascular System.”
 
Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind less than 70 percent less metal than stents.1 Additionally, the Tack Endovascular System offers low radial force, designed to promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients.
 
References
1. Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-17 08:58:00 [updated_at] => 2018-12-17 09:11:31 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["303180","289765","289756","290022","289745","289790","289757","302111","299797","301733","289746","300701","299793","297829","289796","299952","289761","302321"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306276 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181309 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Baxter Appoints Two Industry Veterans to its Board of Directors [short_title] => [summary] => Additions reflect the company's ongoing board refreshment efforts and commitment to further diversification. [slug] => baxter-appoints-two-industry-veterans-to-its-board-of-directors [body] => Baxter International Inc., a global medical products company, has appointed Patricia B. (Patty) Morrison, former Cardinal Health executive vice president and chief information officer, and Amy A. Wendell, former Covidien senior vice president of strategy and business development, to its board of directors. These appointments will be effective Feb. 18, in conjunction with the next regularly scheduled meeting of the board, and will bring the total number of directors serving the company to 14. Morrison will serve on Baxter’s Audit Committee and Wendell will serve on its Quality, Compliance and Technology Committee.
 
“We are pleased to welcome Patty and Amy to Baxter’s board,” said José (Joe) E. Almeida, chairman and CEO. “Their deep corporate leadership experience and differentiated expertise in their respective fields will enhance and further diversify our current board membership. I’m confident their contributions will advance our goal to deliver sustainable top-quartile performance for our shareholders and support our mission to save and sustain lives.”
 
Morrison most recently served as executive vice president, Customer Support Services and chief information officer (CIO), of Cardinal Health, where she led global information technology (IT) operations, which included the transformation of multiple business segments, acquisition integration and digital strategy. Prior to Cardinal, Morrison served as CIO of both Motorola and Office Depot Inc., and held senior-level IT positions at General Electric Co., PepsiCo Inc., The Procter & Gamble Co., and The Quaker Oats Co. Morrison brings to Baxter more than a decade of public board service across six industries and currently serves on the boards of Aramark and Splunk Inc. She received her bachelor’s degrees in education, and mathematics and statistics, from Miami University.
 
Wendell is a senior advisor at Perella Weinberg Partners LP, consulting on strategy, corporate finance and investing practices in the healthcare industry. She previously served as senior vice president of strategy and business development at Covidien plc, where she led the company’s strategy and portfolio management initiatives and managed all business development activities. Wendell held prior roles of increasing responsibility at Covidien (including its predecessors, Tyco Healthcare and Kendall Healthcare Products), from engineering to product management and business development. She currently serves on the boards of Hologic Inc. and Axogen Inc. Wendell earned her bachelor’s degree in mechanical engineering from Lawrence Technological University and her master’s degree in biomedical engineering from the University of Illinois.

Every day, millions of patients and caregivers rely on Baxter’s portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, the company has been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-23 09:11:00 [updated_at] => 2019-01-23 09:17:22 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301035","290592","305183","299201","301638","303180","289765","289756","290022","289745","289768","305196","289744","289761"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 307350 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 182392 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => InnovHeart Appoints New Chief Executive Officer and Board Member [short_title] => [summary] => Company's latest leader has more than 22 years of experience in the medical device industry, including 18 in the interventional cardiovascular market. [slug] => innovheart-appoints-new-chief-executive-officer-and-board-member [body] => InnovHeart s.r.l., developer of transcatheter mitral valve replacement (TMVR) systems for the treatment of cardiac disease, has appointed experienced medical device executive Jason Bottiglieri as CEO and executive member of the Board of Directors. Former CEO and founder Giovanni Righini will continue to serve the company as chief technology officer and as member of the board.
 
Bottiglieri has more than 22 years of experience in the medical device industry, including 18 in the interventional cardiovascular market. Before joining InnovHeart, Bottiglieri was CEO of Infraredx, a startup company developing an intravascular imaging system for the detection of lipid core plaque in coronary artery disease. Under his leadership, Infraredx was acquired by Nipro Corporation, confirming him as CEO of the company. Prior to Infraredx, Bottiglieri was one of the founding U.S. sales leaders in the Italy-based Invatec company. During this period Invatec was acquired by Medtronic plc and became the foundation of its peripheral vascular business unit. Bottiglieri's management experience also includes leadership positions at Spectranetics Corp. and Cordis, a Johnson & Johnson company, where he directed global training and was part of a core team assembled to launch the world's first drug-eluting stent (Cypher).  
 
"The Saturn mitral valve and delivery system is very unique with clinically important features that could prove game changing for patients," said Bottiglieri. "Under Giovanni's leadership the company has made extraordinary advancements in a very short time frame. I am honored and inspired by the opportunity to join this talented team and look forward to making InnovHeart's technology the gold standard for mitral valve replacement." 
 
Board Chairman Dr. Keith Dawkins added, 'We are delighted that Jason has joined InnovHeart. He brings an impressive medical device industry skill-set that will fit well with the company philosophy. It is an important time for InnovHeart, and I am confident that under Jason's leadership, we will realize the goal of bringing our unique minimally invasive Saturn technology to the treatment of patients with mitral valve disease.
 
InnovHeart s.r.l., with operations in Colleretto Giacosa (Italy) and Poway, Calif., develops the Saturn System, a transcatheter mitral valve replacement (TMVR) platform intended to treat patients suffering from mitral valve disease. Saturn's design allows the clinician to accurately deliver the prosthesis in the anatomically correct position, providing a stable and durable anchorage and sealing to the implant site. The system's sub-annular ring affords inverse remodeling of the mitral annulus, and the low profile of the prosthesis ensures unimpeded flow from the left ventricle after implantation. The company is in late preclinical development of the Saturn TA System designed for trans-apical delivery, and planned to enter human use the first half of next year. A trans-septal system is also in development and will enter human studies following transapical validation.
 
InnovHeart is backed by Genextra S.p.A, Italian holding company specialized in early-stage investments in the life sciences sector.
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-02-06 11:13:00 [updated_at] => 2019-02-06 11:22:19 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["307348","302111","301256","294748","303313","306548","300284","305855","300778","303783","296400","306622","297162","305282","305694","301358","301830","296393","296990","294183","298185"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 309278 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2019-03-01 [author_name] => {"name":"Michael Barbella","title":"Managing Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 184317 [primary_image_old] => [slider_image_id] => 184319 [banner_image] => 0 [title] => Free Flow: A Look at the Current State of Stents [short_title] => [summary] => New designs and advancements in polymer technology are driving growth in the global coronary stent market. [slug] => free-flow-a-look-at-the-current-state-of-stents [body] => Not every new technology is recognized or celebrated for its revolutionary potential.

Granted, not every innovation is the eyebrow-raising, history-making, life-changing kind of breakthrough destined to change the course of humanity, but those that have initially were unappreciated, underestimated, and feared at their debut.

Consider the fine art of writing, which arguably was the most important invention for the development of civilization. It was panned at first by Socrates, who reportedly feared it would induce forgetfulness into its practitioners. “...they will not practice using their memory because they will put their trust in writing, which is external and depends on signs that belong to others, instead of trying to remember from the inside, completely on their own,” the classical Greek philosopher contemplated in the myth of Thamus and Theuth (or Thoth, the Egyptian god of writing). ”Your invention will enable them to hear many things without being properly taught, and they will imagine that they have come to know much while for the most part they will know nothing.”

A rather harsh assessment from the “father” of Western thought, no? Nevertheless, Socrates’ quick brush-off of writing epitomizes the technological skepticism that has existed throughout recorded (written) history.

More than 1,900 years after Socrates summarily dismissed the power of prose, the monk and leading scholar Johannes Trithemius predicted the printing press’ swift demise. “The word written on parchment will last a thousand years,” he boasted. “The printed word is on paper...The most you can expect a book of paper to survive is two hundred years.”

Nearly four centuries later (1876), The New York Times lambasted German scientist and telephone inventor Philipp Reis for conspiring to empty concert halls and churches during America’s Centennial celebration, deeming the calling device “a dark design” contrived by U.S. enemies. The invention’s subsequent incantations triggered their fair share of diffidence, too: Mobile telephony pioneer Marty Cooper presumed cell phones would never be popular or cheap enough for mass appeal, and journalists virtually panned the iPhone during its 2007 launch.  “Apple should pull the plug on the iPhone,” MarketWatch columnist John C. Dvorak wrote. “What Apple risks here is its reputation as a hot company that can do no wrong.”

“Apple will sell a few to its fans, but it won’t make a long-term mark on the industry,” Bloomberg writer Matthew Lynn anticipated.

Microsoft’s then-CEO Steve Ballmer agreed. “There’s no chance the iPhone is going to get any significant market share,” he told USA Today. “No chance.”

The odds seemed just as dismal for Andreas R. Gruentzig, M.D., a German radiologist/cardiologist and balloon angioplasty inventor. Gruentzig is renowned for devising the balloon-tipped catheter, a device regarded as one of the most important technological and therapeutic healthcare advancements of the 20th century.

Though he is widely credited with the idea, Gruentzig actually borrowed the balloon angioplasty concept from U.S. vascular radiologist Charles Theodore Dotter, an intelligent but flamboyant risk-taker who described flow-directed balloon catheterization, the double-lumen balloon catheter, the safety guidewire, and percutaneous arterial stenting more than a decade before his German counterpart.

Not surprisingly, Dotter’s ideas and the primitive catheters he created were arbitrarily dismissed by U.S. vascular surgeons (doctors nicknamed him “Crazy Charlie”). But he was a virtual celebrity overseas, where the progressive European medical community almost immediately recognized Dotter’s work for its game-changing cardiac treatment potential.

Gruentzig first learned of Dotter’s catheter-based arterial dilation technique (dubbed Dottern in Germany) during a lecture in Frankfurt. Intrigued, he began developing balloons strong enough to compress lesions and millimeter-sized catheters capable of monitoring pressure, maintaining blood flow, and passing fluid into the balloons for inflation.

Gruentzig’s finished design consisted of a catheter with a small inflatable balloon molded to its tip; the first devices were somewhat rudimentary but nonetheless customized for individual patients on the late doctor’s kitchen table with the help of his assistant and their respective spouses.

Buoyed by multiple successful femoral procedures, Gruentzig performed the world’s first coronary angioplasty in September 1977 on 37-year-old angina patient Adolph Bachman. In a documentary marking the 35th anniversary of the radical surgery, Bachman recounted the confidence he felt in both Gruentzig and the procedure itself, even though it had never before been attempted in humans.

“Everything was so clear. Even as a total layman, I understood his method,” Bachman recalled in the film. “I understood what was going to go on. And I knew there was no reason to worry. I was 100 percent convinced that it [the surgery] would be successful. But that was all because Dr. Gruentzig was so clear and because the method itself was so simple.”

Procedural simplicity, however, failed to quell the skepticism Gruentzig faced over his innovation. Fueling those misgivings was the various complications that plagued the initial procedures—difficulties like restenosis (a possibility in 20 percent or more of the cases), acute dissection, and occlusion. Large dissections were particularly problematic, as they could only be repaired through emergency bypass surgery. Thus, all early angioplasties required backup surgical teams.

“I remember Dr. Gruentzig coming to the NHLBI [National Heart, Lung, and Blood Institute] and giving us a lecture about [balloon angioplasty] being the greatest way to treat coronary disease,” Renu Virmani, M.D., internationally renowned cardiovascular pathologist and CVPath Institute president, told Cardiology Today in a 2011 interview. “Some of us said at that time it didn’t sound like a smart idea.”

Neither did stents at first. Developed explicitly to overcome the limitations of angioplasty, the tiny tube-shaped devices resolved to prevent recoil and restenosis (vessel renarrowing) by permanently propping open arterial walls. An ingenious concept, for certain, but the innovation beget its own set of shortcomings.

“My first impressions with stents were that they were weird-looking and didn’t deploy properly,” Virmani recalled. “The problems had to do with the quality of the balloons and the deployment, as well as how much may have slipped off the stent. Those understandings weren’t there in those days.”

Also missing was an understanding of the necessary components for a successful product (composition, architecture, manufacturing techniques, etc.). Exploratory stent models, for example, featured self-expanding springs or coils that impeded delivery and led to complications. Others lacked flexibility or the tensile strength needed to withstand the multiple forces occurring within coronary arteries.

Julio Palmaz, M.D., an Argentinian-born cardiologist and vascular radiologist, eventually hit upon the winning formula, substituting the springs and coils present in earlier stent designs with a balloon-expandable stainless steel metal tube. Palmaz based his version on a metal lathe he found abandoned in his garage; the discovery led to an “aha!” moment about the elasticity of hole-filled metal tubing.  

Palmaz’s stent—which he co-developed with (then) Brooke Army Medical Center cardiologist Richard A. Schatz and his colleagues—was tested in canine coronary arteries in 1985 before being implanted in humans two years later. The U.S. Food and Drug Administration (FDA) approved the device for use in peripheral vessels in 1991 and in coronary arteries in 1994; Johnson & Johnson, which invested more than $100 million to develop the product, enjoyed a virtual monopoly on the early stent market, capturing a 90 percent share. The company purchased Palmaz’s patent on the device in 1998.

The Palmaz-Schatz stent dominated the burgeoning percutaneous coronary intervention market for much of the 1990s, even as rival devices emerged from Cook Group (Flexstent); Cordis Corporation (Cordis); Medtronic (Wiktor); Applied Vascular Engineering Inc. (Micro); and Advanced Cardiovascular Systems Inc. (Multi-Link).

The first stents were made from stainless steel (316L SS containing iron, nickel, chromium, molybdenum), but later iterations used cobalt chromium and platinum chromium to improve both strength and visibility. Although these devices reduced elastic recoil and restenosis, they were bulky and technically challenging to use, resulting in frequent deployment and embolization failures. The all-metal stents also were associated with higher rates of in-stent restenosis and sub-acute stent thrombosis, the latter of which is a potentially fatal complication occurring up to 30 days after implantation.

“Bare metal stents are seldom used, and are often saved for use only in high-bleeding risk and elderly patients due to concerns of bleeding from dual anti-platelet  therapy after DES implantation,” noted Tim Girton, vice president of Interventional Cardiology research and development at Boston Scientific Corp. “However, recent clinical evidence from the newest biodegradable polymer-coated stents suggests that BMS [bare metal stents] no longer have a role even in that patient subset.”

Maybe so, but bare metal stents are far from extinct. The products are still among the viable treatment options offered by major cardiovascular solution providers, and they still routinely win regulatory support. Case in point: The FDA two years ago approved Biotronik’s Pro-Kinetic Energy BMS, a device designed to improve coronary luminal diameter in patients with new and recurring coronary artery blockages; the stent, according to the company, features an “ultra-thin” (60µm) strut that allows for “optimal deliverability under extreme tortuosity and calcification.”

Similarly, Medtronic received FDA approval last fall for its Valiant Navion thoracic stent graft system for repairing (via a minimally invasive approach) all descending thoracic aortic lesions, including thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural haematomas, and aortic type B dissections. The system features both CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations; an investigational device exemption study showed the latter option implanted successfully (without deployment or access failures) in nearly three-quarters of procedures.

Further cementing BMS’ market longevity is a 2016 Norwegian coronary stent trial (NORSTENT) that found statistically equivalent survival rates between BMS and drug-eluting stent (DES) recipients (17.1 percent vs. 16 percent). In addition to proving BMS safety and efficacy, the study demonstrated the devices’ impressive evolution over the past 30 years—restenosis risk is now 10 percent over six years (compared with 30-40 percent after 12 months in the 1990s) and stent thrombosis is currently 1 percent over six years (down from 10-15 percent three decades ago).

Despite such dramatic improvements, however, BMS remain a second-rate treatment alternative, having long taken a back seat to drug-eluting stents. Developed to address their predecessors’ high restenosis rates and reduce the need for revascularization, DES consist of a bare metal device coated with a medicine to suppress arterial renarrowing.

Cordis was the first to market with a DES, receiving CE mark approval in 2002 and FDA clearance in 2003 for the Cypher sirolimus-eluting stent. Clinical studies showed Cypher significantly reduced neointimal hyperplasia, in-stent restenosis, and major adverse cardiac event rates up to four years after implantation.        
 
The Cypher’s trial data decisively proved the DES concept, opening the floodgates for competing devices and spawning a market worth $6.2 billion last year. Rising cardiovascular disease rates and increasing demand for minimally invasive surgery is expected to drive the sector’s projected 4.7 percent annual growth rate through 2026, pushing its global value past $9 billion.

“Over the past five years, the coronary drug-eluting stent market has transitioned to a relatively mature market,” Girton said. “Current procedural volume growth is modest and largely due to an aging population combined with improved stents and delivery systems allowing the treatment of more complex patients. In the U.S. market, drug-eluting stents are experiencing the most procedural volume growth. Current generation drug-eluting stents are incredibly effective and have an excellent safety profile.”

Such efficacy is due mainly to new designs as well as the evolution of polymers and anti-restenotic drugs used in stent composition. Early DES incorporated medication into permanent synthetic polymers whereas newer models use more biocompatible materials such as poly vinylidene fluoride, hexofluropropylene, and polyvinyl pyrollidone. Similarly, stents’ immunosuppressive coatings have diversified to include the “limus” family of drugs (amphilimus, everolimus, novolimus, umirolimus, zotarolimus) along with the early favorites—sirolimus (a natural antibiotic) and paclitaxel (a chemotherapy drug).

All drug-eluting stents have the same basic elements: A bare metal framework coated with a polymer that gradually releases an immunosuppressant over time to inhibit arterial renarrowing. The ingenuity in these devices lies in the physical design (type of metal used, strut thickness, strut interlinkage mechanics), the specific anti-restenotic drug used, and the polymer’s release characteristics (amount released and rapidity).

Medtronic’s Resolute Onyx DES, for example, has thinner struts and features Core Wire technology, a manufacturing method unique to the company that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. The innovation enables greater deliverability and conformability to the vessel wall, according to the company. Last winter, Medtronic won FDA approval for the 2-millimeter version of the Onyx, the only device of that size currently available in the United States.

Abbott, meanwhile, updated the design of its market-leading XIENCE stent system in May 2018, integrating a thinner profile, increased flexibility, longer lengths, and small diameters into the Sierra model. Company executives said the new system was developed to treat complex cases, including patients with multiple or totally blocked vessels.

XIENCE, however, could face some serious competition from MicroPort’s Firehawk DES, a thin-strut device featuring a biodegradable polymer drug delivery system. The 86-mcm cobalt chromium stent contains abluminal grooves that release rapamycin (a.k.a., sirolimus) directly to the affected artery wall, exposing patients to only one-third as much active drug as other drug-eluting devices, the company asserts. Ninety percent of the rapamycin is released within 90 days after implantation.

The Firehawk’s clinical proficiencies have been proven both in China and Europe. A European study (TARGET All Comers) found Firehawk to be equally as safe and effective as XIENCE; the device’s 12-month target lesion failure rate was 6.1 percent compared with 5.9 percent for the Abbott stent. In addition, the target lesion revascularization rate was lower in the Firehawk group and the stent thrombosis rate was the same for both devices, according to trial data.

The TARGET All Comers results currently are being incorporated into an FDA study. The Firehawk stent already is approved for use in Europe.

“Stent research, design, manufacturing, and the clinical studies required to bring them to the U.S. market require decades of dedication and millions [of dollars] in capital investment,”said Dr. Alexander Uhl, senior vice president, corporate marketing, at Biotronik, a global developer, manufacturer, and seller of cardiovascular products and equipment. “At Biotronik, we never rush to market. We research, innovate, and develop, then significantly invest in clinical studies to prove the capabilities of our products.”

The company’s formula has resulted in such innovations as the PK Papyrus stent and Orsiro DES system. The former device—designed to treat acute coronary perforations, or blood vessel tears within the heart—was the first stent in 17 years to be approved by the FDA for such an indication (September 2018).

Built on Biotronik’s ultra-thin stent platform, the PK Papyrus System is designed for use in arteries measuring 2.5mm to 5mm in diameter. The covered stent is available in 17 sizes, expanding treatment options and helping avoid the need for emergency coronary artery bypass grafting. Biotronik claims the PK Papyrus is the only 5 French compatible covered coronary stent currently available in the United States. Company data indicate the covered stent is 58 percent more flexible and has a 23 percent smaller crossing profile compared to Graftmaster (JOSTENT). The latter product has a layered dual-stent design and is the only other covered coronary stent available in the United States.

“The PK Papyrus is a unique, life-saving technology that is an important part of this portfolio. We invested in the development of PK Papyrus to meet a critical need in interventional cardiology,” Uhl told Medical Product Outsourcing. “While coronary artery perforation is very uncommon—less than 4,000 per year in the United States—physicians must be fully prepared for this emergency event in order to save lives. When a perforation occurs during a percutaneous coronary intervention procedure, physicians need a reliable covered stent that can be deployed quickly. Designed to deliver when seconds count, PK Papyrus is engineered on a single-stent, ultrathin strut platform that makes it more flexible and gives it a low crossing profile. Because of these features, PK Papyrus delivers more like a conventional stent with 5 French compatibility. We’ve improved every aspect of previous covered stents, transforming what was once a dreaded emergency use device into a reliable solution that physicians can deploy with confidence in critical situations.”

Biotronik followed up its PK Papyrus approval with the FDA’s February ratification of the Orsiro stent, the first and only ultrathin DES to outperform Abbott’s XIENCE. Orsiro received CE marking in 2011 and has been used to treat more than 1 million patients worldwide to date.  
 
For use in percutaneous coronary intervention (PCI) procedures, the cobalt chromium metal stent elutes sirolimus via BIOlute, Biotronik’s bioabsorbable polymer coating. Beneath the bioabsorbable layer is proBIO, a passive coating on the bare metal surface designed to reduce nickel ion release. The Orsiro stent system provides ultrathin stent struts without compromising radial strength, and a low crossing profile for easier lesion cross in complex PCI. The device is available in 52 sizes ranging from 2.25mm to 4mm in diameter and lengths up to 40 mm, the longest available in the United States.

“The BIOFLOW V pivotal trial shows Biotronik’s ultra-thin Orsiro DES has demonstrated sustained improvement over XIENCE at multiple clinical endpoints,” Uhl explained. “Orsiro’s outcomes may shift the market back toward a greater focus on clinical data. Outcomes data is what really matters when creating and embracing value-based care. The U.S. DES market has suffered for too long from a lack of innovation. Orsiro is poised to disrupt the U. S. market with its ultrathin stent technology. Physicians have been impressed by the superior performance and clinical outcome data proven in regulatory and pivotal clinical trials. For hospitals and health systems, outcomes data is paramount to providing the best possible patient care. Complacency isn’t an option.”

Nor will it ever be again.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-03-07 11:02:31 [updated_at] => 2019-03-07 11:06:56 [last_updated_author] => 195666 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["309242","308758","308204","308082","308066","305855","305410","305051","303783","303649","308863","308218","305910","305696","300780","300499","300283","299288","306112","300913"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 303180 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Cardinal Health","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178748 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => FDA Approves Cardinal Health's INCRAFT AAA Stent Graft System [short_title] => [summary] => The flexible endovascular aneurysm repair system treats infrarenal abdominal aortic aneurysms. [slug] => fda-approves-cardinal-healths-incraft-aaa-stent-graft-system [body] => Cordis, a Cardinal Health company announced that the U.S. Food and Drug Administration (FDA) has approved its INCRAFT AAA Stent Graft System for use in complex access anatomies. The INCRAFT system is an ultra-low profile and flexible endovascular aneurysm repair (EVAR) system designed to treat infrarenal abdominal aortic aneurysms (AAA).
 
The INCRAFT system was given a favorable recommendation on June 12 by a Circulatory System Devices Panel of the Medical Devices Advisory Committee, following a review of clinical data from the pivotal INSPIRATION trial, a prospective, multi-center, single-arm study designed to evaluate the safety and effectiveness of the INCRAFT system in patients with AAA. The trial showed that the INCRAFT system met the primary safety and effectiveness endpoints, with a low rate of major adverse events at 30 days, high rates of successful aneurysm treatment and survival, and no aneurysm ruptures through four years of follow up.
 
“We welcome the recent FDA approval of the INCRAFT stent graft system which offers U.S. physicians a treatment option for patients with AAAs who otherwise might not be suitable for other EVAR devices,” said Dr. Michel Makaroun, M.D., Professor and Chair of vascular surgery at the University of Pittsburgh Medical Center, and Co-Principal Investigator of the INSPIRATION study. “While EVAR systems have advanced rapidly over the years, there still remains a need for a low-profile EVAR device that is designed to be easy to deliver in complex access anatomies while facilitating precise placement.”
 
“INCRAFT is an attractive new ultra-low profile EVAR option that allows for bilateral in-situ adjustment during the procedure, helping to minimize the need for additional components or extensions,” said Dr. Takao Ohki, Chairman and Professor of Surgery and Chief of Vascular Surgery at the Jikei University School of Medicine in Tokyo, Japan and Co-Principal Investigator of the INSPIRATION study.
 
While several EVAR devices are currently available in the U.S., treatment options are limited for many AAA patients with small femoral or iliac arteries or with heavily calcified or tortuous vessels that could lead to complications during the introduction of EVAR devices.
 
“We are excited to announce INCRAFT FDA approval, which will enable high-risk AAA patients in the U.S. to benefit from more than a decade of investment in R&D and clinical research,” said Patrick Holt, president of Cordis at Cardinal Health. “Cordis continues to invest in expanding our product offering to meet our global customers’ needs, whether via innovations like our Mynx Control Vascular Closure Device and our RADIAL 360 portfolio, or via strategic alliances, which brought the EluNIR drug-eluting coronary stent to the U.S.”
 
The INCRAFT system, which received a CE (Conformité Européenne) mark in 2014, is commercially available in many global geographies, including Canada and countries in the European Union, the Middle East, South America, and Asia Pacific. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-29 11:04:00 [updated_at] => 2018-11-29 11:08:34 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["289765","289756","290022","289745","282690","289790","289757","302111","299797","284487","302836","299288","302016","282688","300250","302305","283697","302922","282390","296562","282544","282670"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304362 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179653 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Intact Vascular Hires Industry Veteran as Vice President of Sales [short_title] => [summary] => Prior to joining Intact Vascular, new hire was the vice president of U.S. sales for Neuronetics. [slug] => intact-vascular-hires-industry-veteran-as-vice-president-of-sales [body] => Intact Vascular Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, announced that Steve MacKinnon has joined its senior management team as vice president of Sales, effective immediately. Reporting to the CEO, MacKinnon will oversee the creation of a U.S. based sales team and will play a central role in planning and executing the company’s projected launch of the Tack Endovascular System in 2019.
 
“Steve brings a stellar track record of sales achievement across a broad range of entrepreneurial medical technology companies,” said Bruce Shook, Intact Vascular’s president and CEO. “Steve’s experience with creating and motivating high performance sales teams, coupled with his deep knowledge of the peripheral vascular market, will be tremendous assets to us as we move toward launch of our flagship product next year.”
 
Prior to joining Intact Vascular, MacKinnon was the vice president of U.S. Sales for Neuronetics, where he significantly expanded the sales team and product revenue, and helped take the company public. Prior to Neuronetics, Steve served as vice president of U.S. Sales for Access Closure and was instrumental in its successful merger with Cardinal Health. He also held multiple sales positions with Fox Hollow Technologies prior to its sale to eV3.
 
“Intact Vascular represents an exciting opportunity to bring high-value innovations to peripheral vascular patients,” said Steve MacKinnon. “I look forward to building a world class sales organization at Intact and to a very successful launch of the Tack Endovascular System.”
 
Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to improve peripheral balloon angioplasty results in the treatment of peripheral arterial disease. Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind less than 70 percent less metal than stents.1 Additionally, the Tack Endovascular System offers low radial force, designed to promote healing, improve outcomes and preserve future treatment options for PAD and critical limb ischemia (CLI) patients.
 
References
1. Bosiers M, Scheinert D, Hendricks JMH et al. Results from the Tack Optimized Balloon Angioplasty (TOBA) study demonstrate the benefits of minimal metal implants for dissection repair after angioplasty. J Vasc Surg 2016;64:109-16. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-17 08:58:00 [updated_at] => 2018-12-17 09:11:31 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["303180","289765","289756","290022","289745","289790","289757","302111","299797","301733","289746","300701","299793","297829","289796","299952","289761","302321"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306276 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"Business Wire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181309 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Baxter Appoints Two Industry Veterans to its Board of Directors [short_title] => [summary] => Additions reflect the company's ongoing board refreshment efforts and commitment to further diversification. [slug] => baxter-appoints-two-industry-veterans-to-its-board-of-directors [body] => Baxter International Inc., a global medical products company, has appointed Patricia B. (Patty) Morrison, former Cardinal Health executive vice president and chief information officer, and Amy A. Wendell, former Covidien senior vice president of strategy and business development, to its board of directors. These appointments will be effective Feb. 18, in conjunction with the next regularly scheduled meeting of the board, and will bring the total number of directors serving the company to 14. Morrison will serve on Baxter’s Audit Committee and Wendell will serve on its Quality, Compliance and Technology Committee.
 
“We are pleased to welcome Patty and Amy to Baxter’s board,” said José (Joe) E. Almeida, chairman and CEO. “Their deep corporate leadership experience and differentiated expertise in their respective fields will enhance and further diversify our current board membership. I’m confident their contributions will advance our goal to deliver sustainable top-quartile performance for our shareholders and support our mission to save and sustain lives.”
 
Morrison most recently served as executive vice president, Customer Support Services and chief information officer (CIO), of Cardinal Health, where she led global information technology (IT) operations, which included the transformation of multiple business segments, acquisition integration and digital strategy. Prior to Cardinal, Morrison served as CIO of both Motorola and Office Depot Inc., and held senior-level IT positions at General Electric Co., PepsiCo Inc., The Procter & Gamble Co., and The Quaker Oats Co. Morrison brings to Baxter more than a decade of public board service across six industries and currently serves on the boards of Aramark and Splunk Inc. She received her bachelor’s degrees in education, and mathematics and statistics, from Miami University.
 
Wendell is a senior advisor at Perella Weinberg Partners LP, consulting on strategy, corporate finance and investing practices in the healthcare industry. She previously served as senior vice president of strategy and business development at Covidien plc, where she led the company’s strategy and portfolio management initiatives and managed all business development activities. Wendell held prior roles of increasing responsibility at Covidien (including its predecessors, Tyco Healthcare and Kendall Healthcare Products), from engineering to product management and business development. She currently serves on the boards of Hologic Inc. and Axogen Inc. Wendell earned her bachelor’s degree in mechanical engineering from Lawrence Technological University and her master’s degree in biomedical engineering from the University of Illinois.

Every day, millions of patients and caregivers rely on Baxter’s portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, the company has been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-23 09:11:00 [updated_at] => 2019-01-23 09:17:22 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["301035","290592","305183","299201","301638","303180","289765","289756","290022","289745","289768","305196","289744","289761"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 307350 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2487 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => [author_name] => {"name":"PR Newswire","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 182392 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => InnovHeart Appoints New Chief Executive Officer and Board Member [short_title] => [summary] => Company's latest leader has more than 22 years of experience in the medical device industry, including 18 in the interventional cardiovascular market. [slug] => innovheart-appoints-new-chief-executive-officer-and-board-member [body] => InnovHeart s.r.l., developer of transcatheter mitral valve replacement (TMVR) systems for the treatment of cardiac disease, has appointed experienced medical device executive Jason Bottiglieri as CEO and executive member of the Board of Directors. Former CEO and founder Giovanni Righini will continue to serve the company as chief technology officer and as member of the board.
 
Bottiglieri has more than 22 years of experience in the medical device industry, including 18 in the interventional cardiovascular market. Before joining InnovHeart, Bottiglieri was CEO of Infraredx, a startup company developing an intravascular imaging system for the detection of lipid core plaque in coronary artery disease. Under his leadership, Infraredx was acquired by Nipro Corporation, confirming him as CEO of the company. Prior to Infraredx, Bottiglieri was one of the founding U.S. sales leaders in the Italy-based Invatec company. During this period Invatec was acquired by Medtronic plc and became the foundation of its peripheral vascular business unit. Bottiglieri's management experience also includes leadership positions at Spectranetics Corp. and Cordis, a Johnson & Johnson company, where he directed global training and was part of a core team assembled to launch the world's first drug-eluting stent (Cypher).  
 
"The Saturn mitral valve and delivery system is very unique with clinically important features that could prove game changing for patients," said Bottiglieri. "Under Giovanni's leadership the company has made extraordinary advancements in a very short time frame. I am honored and inspired by the opportunity to join this talented team and look forward to making InnovHeart's technology the gold standard for mitral valve replacement." 
 
Board Chairman Dr. Keith Dawkins added, 'We are delighted that Jason has joined InnovHeart. He brings an impressive medical device industry skill-set that will fit well with the company philosophy. It is an important time for InnovHeart, and I am confident that under Jason's leadership, we will realize the goal of bringing our unique minimally invasive Saturn technology to the treatment of patients with mitral valve disease.
 
InnovHeart s.r.l., with operations in Colleretto Giacosa (Italy) and Poway, Calif., develops the Saturn System, a transcatheter mitral valve replacement (TMVR) platform intended to treat patients suffering from mitral valve disease. Saturn's design allows the clinician to accurately deliver the prosthesis in the anatomically correct position, providing a stable and durable anchorage and sealing to the implant site. The system's sub-annular ring affords inverse remodeling of the mitral annulus, and the low profile of the prosthesis ensures unimpeded flow from the left ventricle after implantation. The company is in late preclinical development of the Saturn TA System designed for trans-apical delivery, and planned to enter human use the first half of next year. A trans-septal system is also in development and will enter human studies following transapical validation.
 
InnovHeart is backed by Genextra S.p.A, Italian holding company specialized in early-stage investments in the life sciences sector.
[views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-02-06 11:13:00 [updated_at] => 2019-02-06 11:22:19 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["307348","302111","301256","294748","303313","306548","300284","305855","300778","303783","296400","306622","297162","305282","305694","301358","301830","296393","296990","294183","298185"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 309278 [pageNumber] => [offset] => [totalPages] => [last_query] => [last_sql] => [show_errors] => 1 [databaseServer] => Array ( [key] => master [host] => 172.24.16.232 [user] => rodpub_beta [pass] => MvQQzhse92k58yA [db] => rodpub_beta ) [tableName] => contents [content_type_id] => 2486 [resource_id] => 0 [author_id] => 0 [primary_issue_slug] => 2019-03-01 [author_name] => {"name":"Michael Barbella","title":"Managing Editor"} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 184317 [primary_image_old] => [slider_image_id] => 184319 [banner_image] => 0 [title] => Free Flow: A Look at the Current State of Stents [short_title] => [summary] => New designs and advancements in polymer technology are driving growth in the global coronary stent market. [slug] => free-flow-a-look-at-the-current-state-of-stents [body] => Not every new technology is recognized or celebrated for its revolutionary potential.

Granted, not every innovation is the eyebrow-raising, history-making, life-changing kind of breakthrough destined to change the course of humanity, but those that have initially were unappreciated, underestimated, and feared at their debut.

Consider the fine art of writing, which arguably was the most important invention for the development of civilization. It was panned at first by Socrates, who reportedly feared it would induce forgetfulness into its practitioners. “...they will not practice using their memory because they will put their trust in writing, which is external and depends on signs that belong to others, instead of trying to remember from the inside, completely on their own,” the classical Greek philosopher contemplated in the myth of Thamus and Theuth (or Thoth, the Egyptian god of writing). ”Your invention will enable them to hear many things without being properly taught, and they will imagine that they have come to know much while for the most part they will know nothing.”

A rather harsh assessment from the “father” of Western thought, no? Nevertheless, Socrates’ quick brush-off of writing epitomizes the technological skepticism that has existed throughout recorded (written) history.

More than 1,900 years after Socrates summarily dismissed the power of prose, the monk and leading scholar Johannes Trithemius predicted the printing press’ swift demise. “The word written on parchment will last a thousand years,” he boasted. “The printed word is on paper...The most you can expect a book of paper to survive is two hundred years.”

Nearly four centuries later (1876), The New York Times lambasted German scientist and telephone inventor Philipp Reis for conspiring to empty concert halls and churches during America’s Centennial celebration, deeming the calling device “a dark design” contrived by U.S. enemies. The invention’s subsequent incantations triggered their fair share of diffidence, too: Mobile telephony pioneer Marty Cooper presumed cell phones would never be popular or cheap enough for mass appeal, and journalists virtually panned the iPhone during its 2007 launch.  “Apple should pull the plug on the iPhone,” MarketWatch columnist John C. Dvorak wrote. “What Apple risks here is its reputation as a hot company that can do no wrong.”

“Apple will sell a few to its fans, but it won’t make a long-term mark on the industry,” Bloomberg writer Matthew Lynn anticipated.

Microsoft’s then-CEO Steve Ballmer agreed. “There’s no chance the iPhone is going to get any significant market share,” he told USA Today. “No chance.”

The odds seemed just as dismal for Andreas R. Gruentzig, M.D., a German radiologist/cardiologist and balloon angioplasty inventor. Gruentzig is renowned for devising the balloon-tipped catheter, a device regarded as one of the most important technological and therapeutic healthcare advancements of the 20th century.

Though he is widely credited with the idea, Gruentzig actually borrowed the balloon angioplasty concept from U.S. vascular radiologist Charles Theodore Dotter, an intelligent but flamboyant risk-taker who described flow-directed balloon catheterization, the double-lumen balloon catheter, the safety guidewire, and percutaneous arterial stenting more than a decade before his German counterpart.

Not surprisingly, Dotter’s ideas and the primitive catheters he created were arbitrarily dismissed by U.S. vascular surgeons (doctors nicknamed him “Crazy Charlie”). But he was a virtual celebrity overseas, where the progressive European medical community almost immediately recognized Dotter’s work for its game-changing cardiac treatment potential.

Gruentzig first learned of Dotter’s catheter-based arterial dilation technique (dubbed Dottern in Germany) during a lecture in Frankfurt. Intrigued, he began developing balloons strong enough to compress lesions and millimeter-sized catheters capable of monitoring pressure, maintaining blood flow, and passing fluid into the balloons for inflation.

Gruentzig’s finished design consisted of a catheter with a small inflatable balloon molded to its tip; the first devices were somewhat rudimentary but nonetheless customized for individual patients on the late doctor’s kitchen table with the help of his assistant and their respective spouses.

Buoyed by multiple successful femoral procedures, Gruentzig performed the world’s first coronary angioplasty in September 1977 on 37-year-old angina patient Adolph Bachman. In a documentary marking the 35th anniversary of the radical surgery, Bachman recounted the confidence he felt in both Gruentzig and the procedure itself, even though it had never before been attempted in humans.

“Everything was so clear. Even as a total layman, I understood his method,” Bachman recalled in the film. “I understood what was going to go on. And I knew there was no reason to worry. I was 100 percent convinced that it [the surgery] would be successful. But that was all because Dr. Gruentzig was so clear and because the method itself was so simple.”

Procedural simplicity, however, failed to quell the skepticism Gruentzig faced over his innovation. Fueling those misgivings was the various complications that plagued the initial procedures—difficulties like restenosis (a possibility in 20 percent or more of the cases), acute dissection, and occlusion. Large dissections were particularly problematic, as they could only be repaired through emergency bypass surgery. Thus, all early angioplasties required backup surgical teams.

“I remember Dr. Gruentzig coming to the NHLBI [National Heart, Lung, and Blood Institute] and giving us a lecture about [balloon angioplasty] being the greatest way to treat coronary disease,” Renu Virmani, M.D., internationally renowned cardiovascular pathologist and CVPath Institute president, told Cardiology Today in a 2011 interview. “Some of us said at that time it didn’t sound like a smart idea.”

Neither did stents at first. Developed explicitly to overcome the limitations of angioplasty, the tiny tube-shaped devices resolved to prevent recoil and restenosis (vessel renarrowing) by permanently propping open arterial walls. An ingenious concept, for certain, but the innovation beget its own set of shortcomings.

“My first impressions with stents were that they were weird-looking and didn’t deploy properly,” Virmani recalled. “The problems had to do with the quality of the balloons and the deployment, as well as how much may have slipped off the stent. Those understandings weren’t there in those days.”

Also missing was an understanding of the necessary components for a successful product (composition, architecture, manufacturing techniques, etc.). Exploratory stent models, for example, featured self-expanding springs or coils that impeded delivery and led to complications. Others lacked flexibility or the tensile strength needed to withstand the multiple forces occurring within coronary arteries.

Julio Palmaz, M.D., an Argentinian-born cardiologist and vascular radiologist, eventually hit upon the winning formula, substituting the springs and coils present in earlier stent designs with a balloon-expandable stainless steel metal tube. Palmaz based his version on a metal lathe he found abandoned in his garage; the discovery led to an “aha!” moment about the elasticity of hole-filled metal tubing.  

Palmaz’s stent—which he co-developed with (then) Brooke Army Medical Center cardiologist Richard A. Schatz and his colleagues—was tested in canine coronary arteries in 1985 before being implanted in humans two years later. The U.S. Food and Drug Administration (FDA) approved the device for use in peripheral vessels in 1991 and in coronary arteries in 1994; Johnson & Johnson, which invested more than $100 million to develop the product, enjoyed a virtual monopoly on the early stent market, capturing a 90 percent share. The company purchased Palmaz’s patent on the device in 1998.

The Palmaz-Schatz stent dominated the burgeoning percutaneous coronary intervention market for much of the 1990s, even as rival devices emerged from Cook Group (Flexstent); Cordis Corporation (Cordis); Medtronic (Wiktor); Applied Vascular Engineering Inc. (Micro); and Advanced Cardiovascular Systems Inc. (Multi-Link).

The first stents were made from stainless steel (316L SS containing iron, nickel, chromium, molybdenum), but later iterations used cobalt chromium and platinum chromium to improve both strength and visibility. Although these devices reduced elastic recoil and restenosis, they were bulky and technically challenging to use, resulting in frequent deployment and embolization failures. The all-metal stents also were associated with higher rates of in-stent restenosis and sub-acute stent thrombosis, the latter of which is a potentially fatal complication occurring up to 30 days after implantation.

“Bare metal stents are seldom used, and are often saved for use only in high-bleeding risk and elderly patients due to concerns of bleeding from dual anti-platelet  therapy after DES implantation,” noted Tim Girton, vice president of Interventional Cardiology research and development at Boston Scientific Corp. “However, recent clinical evidence from the newest biodegradable polymer-coated stents suggests that BMS [bare metal stents] no longer have a role even in that patient subset.”

Maybe so, but bare metal stents are far from extinct. The products are still among the viable treatment options offered by major cardiovascular solution providers, and they still routinely win regulatory support. Case in point: The FDA two years ago approved Biotronik’s Pro-Kinetic Energy BMS, a device designed to improve coronary luminal diameter in patients with new and recurring coronary artery blockages; the stent, according to the company, features an “ultra-thin” (60µm) strut that allows for “optimal deliverability under extreme tortuosity and calcification.”

Similarly, Medtronic received FDA approval last fall for its Valiant Navion thoracic stent graft system for repairing (via a minimally invasive approach) all descending thoracic aortic lesions, including thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural haematomas, and aortic type B dissections. The system features both CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations; an investigational device exemption study showed the latter option implanted successfully (without deployment or access failures) in nearly three-quarters of procedures.

Further cementing BMS’ market longevity is a 2016 Norwegian coronary stent trial (NORSTENT) that found statistically equivalent survival rates between BMS and drug-eluting stent (DES) recipients (17.1 percent vs. 16 percent). In addition to proving BMS safety and efficacy, the study demonstrated the devices’ impressive evolution over the past 30 years—restenosis risk is now 10 percent over six years (compared with 30-40 percent after 12 months in the 1990s) and stent thrombosis is currently 1 percent over six years (down from 10-15 percent three decades ago).

Despite such dramatic improvements, however, BMS remain a second-rate treatment alternative, having long taken a back seat to drug-eluting stents. Developed to address their predecessors’ high restenosis rates and reduce the need for revascularization, DES consist of a bare metal device coated with a medicine to suppress arterial renarrowing.

Cordis was the first to market with a DES, receiving CE mark approval in 2002 and FDA clearance in 2003 for the Cypher sirolimus-eluting stent. Clinical studies showed Cypher significantly reduced neointimal hyperplasia, in-stent restenosis, and major adverse cardiac event rates up to four years after implantation.        
 
The Cypher’s trial data decisively proved the DES concept, opening the floodgates for competing devices and spawning a market worth $6.2 billion last year. Rising cardiovascular disease rates and increasing demand for minimally invasive surgery is expected to drive the sector’s projected 4.7 percent annual growth rate through 2026, pushing its global value past $9 billion.

“Over the past five years, the coronary drug-eluting stent market has transitioned to a relatively mature market,” Girton said. “Current procedural volume growth is modest and largely due to an aging population combined with improved stents and delivery systems allowing the treatment of more complex patients. In the U.S. market, drug-eluting stents are experiencing the most procedural volume growth. Current generation drug-eluting stents are incredibly effective and have an excellent safety profile.”

Such efficacy is due mainly to new designs as well as the evolution of polymers and anti-restenotic drugs used in stent composition. Early DES incorporated medication into permanent synthetic polymers whereas newer models use more biocompatible materials such as poly vinylidene fluoride, hexofluropropylene, and polyvinyl pyrollidone. Similarly, stents’ immunosuppressive coatings have diversified to include the “limus” family of drugs (amphilimus, everolimus, novolimus, umirolimus, zotarolimus) along with the early favorites—sirolimus (a natural antibiotic) and paclitaxel (a chemotherapy drug).

All drug-eluting stents have the same basic elements: A bare metal framework coated with a polymer that gradually releases an immunosuppressant over time to inhibit arterial renarrowing. The ingenuity in these devices lies in the physical design (type of metal used, strut thickness, strut interlinkage mechanics), the specific anti-restenotic drug used, and the polymer’s release characteristics (amount released and rapidity).

Medtronic’s Resolute Onyx DES, for example, has thinner struts and features Core Wire technology, a manufacturing method unique to the company that involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. The innovation enables greater deliverability and conformability to the vessel wall, according to the company. Last winter, Medtronic won FDA approval for the 2-millimeter version of the Onyx, the only device of that size currently available in the United States.

Abbott, meanwhile, updated the design of its market-leading XIENCE stent system in May 2018, integrating a thinner profile, increased flexibility, longer lengths, and small diameters into the Sierra model. Company executives said the new system was developed to treat complex cases, including patients with multiple or totally blocked vessels.

XIENCE, however, could face some serious competition from MicroPort’s Firehawk DES, a thin-strut device featuring a biodegradable polymer drug delivery system. The 86-mcm cobalt chromium stent contains abluminal grooves that release rapamycin (a.k.a., sirolimus) directly to the affected artery wall, exposing patients to only one-third as much active drug as other drug-eluting devices, the company asserts. Ninety percent of the rapamycin is released within 90 days after implantation.

The Firehawk’s clinical proficiencies have been proven both in China and Europe. A European study (TARGET All Comers) found Firehawk to be equally as safe and effective as XIENCE; the device’s 12-month target lesion failure rate was 6.1 percent compared with 5.9 percent for the Abbott stent. In addition, the target lesion revascularization rate was lower in the Firehawk group and the stent thrombosis rate was the same for both devices, according to trial data.

The TARGET All Comers results currently are being incorporated into an FDA study. The Firehawk stent already is approved for use in Europe.

“Stent research, design, manufacturing, and the clinical studies required to bring them to the U.S. market require decades of dedication and millions [of dollars] in capital investment,”said Dr. Alexander Uhl, senior vice president, corporate marketing, at Biotronik, a global developer, manufacturer, and seller of cardiovascular products and equipment. “At Biotronik, we never rush to market. We research, innovate, and develop, then significantly invest in clinical studies to prove the capabilities of our products.”

The company’s formula has resulted in such innovations as the PK Papyrus stent and Orsiro DES system. The former device—designed to treat acute coronary perforations, or blood vessel tears within the heart—was the first stent in 17 years to be approved by the FDA for such an indication (September 2018).

Built on Biotronik’s ultra-thin stent platform, the PK Papyrus System is designed for use in arteries measuring 2.5mm to 5mm in diameter. The covered stent is available in 17 sizes, expanding treatment options and helping avoid the need for emergency coronary artery bypass grafting. Biotronik claims the PK Papyrus is the only 5 French compatible covered coronary stent currently available in the United States. Company data indicate the covered stent is 58 percent more flexible and has a 23 percent smaller crossing profile compared to Graftmaster (JOSTENT). The latter product has a layered dual-stent design and is the only other covered coronary stent available in the United States.

“The PK Papyrus is a unique, life-saving technology that is an important part of this portfolio. We invested in the development of PK Papyrus to meet a critical need in interventional cardiology,” Uhl told Medical Product Outsourcing. “While coronary artery perforation is very uncommon—less than 4,000 per year in the United States—physicians must be fully prepared for this emergency event in order to save lives. When a perforation occurs during a percutaneous coronary intervention procedure, physicians need a reliable covered stent that can be deployed quickly. Designed to deliver when seconds count, PK Papyrus is engineered on a single-stent, ultrathin strut platform that makes it more flexible and gives it a low crossing profile. Because of these features, PK Papyrus delivers more like a conventional stent with 5 French compatibility. We’ve improved every aspect of previous covered stents, transforming what was once a dreaded emergency use device into a reliable solution that physicians can deploy with confidence in critical situations.”

Biotronik followed up its PK Papyrus approval with the FDA’s February ratification of the Orsiro stent, the first and only ultrathin DES to outperform Abbott’s XIENCE. Orsiro received CE marking in 2011 and has been used to treat more than 1 million patients worldwide to date.  
 
For use in percutaneous coronary intervention (PCI) procedures, the cobalt chromium metal stent elutes sirolimus via BIOlute, Biotronik’s bioabsorbable polymer coating. Beneath the bioabsorbable layer is proBIO, a passive coating on the bare metal surface designed to reduce nickel ion release. The Orsiro stent system provides ultrathin stent struts without compromising radial strength, and a low crossing profile for easier lesion cross in complex PCI. The device is available in 52 sizes ranging from 2.25mm to 4mm in diameter and lengths up to 40 mm, the longest available in the United States.

“The BIOFLOW V pivotal trial shows Biotronik’s ultra-thin Orsiro DES has demonstrated sustained improvement over XIENCE at multiple clinical endpoints,” Uhl explained. “Orsiro’s outcomes may shift the market back toward a greater focus on clinical data. Outcomes data is what really matters when creating and embracing value-based care. The U.S. DES market has suffered for too long from a lack of innovation. Orsiro is poised to disrupt the U. S. market with its ultrathin stent technology. Physicians have been impressed by the superior performance and clinical outcome data proven in regulatory and pivotal clinical trials. For hospitals and health systems, outcomes data is paramount to providing the best possible patient care. Complacency isn’t an option.”

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