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    [title] => Surmodics Enrolls First Patient in TRANSCEND Pivotal Clinical Trial for SurVeil Drug-Coated Balloon
    [short_title] => 
    [summary] =>  Plan to enroll up to 446 patients at approximately 78 sites. 
    [slug] => surmodics-enrolls-first-patient-in-transcend-pivotal-clinical-trial-for-surveil-drug-coated-balloon
    [body] => Surmodics Inc., a provider of medical device and in-vitro diagnostic technologies, has enrolled the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to a commercially available DCB treatment. Up to 446 patients will be randomized 1:1 to receive either the SurVeil DCB or Medtronic’s IN.PACT Admiral DCB at approximately 60 U.S. sites and 18 sites outside the United States.
 
“Based on the preclinical and early feasibility study results we have seen so far, I am excited about the potential of the Surveil DCB as a third-generation DCB to improve the treatment of PAD,” said Kenneth Rosenfield, M.D., section head, Vascular Medicine and Intervention at Massachusetts General Hospital, chair of the Surmodics Clinical Advisory Board and U.S. co-principal investigator for the TRANSCEND trial. “TRANSCEND will be a rigorous Level One trial that will answer important questions about DCB technologies.”
 
The design of the Surveil DCB reflects Surmodics’ long-standing industry leadership in the development of surface technology for vascular medical devices. The device includes a proprietary drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Pre-clinical data have shown a three to five times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to control DCBs.1
 
“This is a major step in the right direction for Surmodics, as we apply and evaluate our unique technology with the goal of improving clinical outcomes for patients with peripheral artery disease,” said Gary Maharaj, president and CEO of Surmodics. “We’re thrilled to be underway with TRANSCEND and look forward to working with our investigators to execute an efficient and rigorous pivotal trial.”
 
The objective of the Surveil DCB pivotal trial, TRANSCEND, is to evaluate the safety and effectiveness of the device for treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support regulatory approvals (U.S. and Europe) and reimbursement. The primary efficacy endpoint of the trial is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization (TLR) through 12 months post-index procedure. All randomized subjects will be followed through 60 months post-index procedure.
 
The trial will be led by national co-principal investigators Kenneth Rosenfield, M.D., and Gary Ansel, M.D., system medical chief of the Vascular Program at OhioHealth. Marianne Brodmann, M.D., substitute head of the Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria, is the European principal investigator.

The Surveil DCB is not available for sale anywhere in the world, and is for investigational use only.
 
Worldwide, over 200 million people have PAD,2 a serious and underdiagnosed circulatory condition caused by build-up of arterial plaque, most commonly in the legs. Twelve to 20 percent of Americans over 60 years old have PAD.3 PAD increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.4
 
Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in-vitro diagnostic (IVD) tests and microarrays. Following two recent acquisitions of Creagh Medical and NorMedix, the company is executing a key growth strategy for its medical device business by expanding to offer total intravascular product solutions to its medical device customers. The combination of proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities, enables Surmodics to significantly increase the value it offers with highly differentiated intravascular solutions designed and engineered to meet the most demanding requirements. With this focus on offering total solutions, Surmodics’ mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minn.
 
References
1. Surmodics data on file
2. Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
3. Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
4. National Institutes of Health. What is Peripheral Artery Disease? n.d. Web. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-11-06 11:11:00 [updated_at] => 2017-11-06 11:16:55 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["259149","258877","257971","257850","254341"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 [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/2017-11-06/surmodics-enrolls-first-patient-in-transcend-pivotal-clinical-trial-for-surveil-drug-coated-balloon/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 254341 [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] => 151153 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Surmodics Receives IDE Approval to Initiate Pivotal Trial of the SurVeil Drug-Coated Balloon [short_title] => [summary] => SurVeil DCB design includes new proprietary coating for interventional treatment of PAD. [slug] => surmodics-receives-ide-approval-to-initiate-pivotal-trial-of-the-surveil-drug-coated-balloon [body] => Surmodics Inc., a provider of medical device and in-vitro diagnostic technologies, has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeil drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to the Medtronic IN.PACT Admiral DCB.
 
The SurVeil DCB pivotal trial will be among the first trials in the United States to compare a next-generation DCB with a commercially-available DCB.
 
“By providing a head-to-head comparison with today’s market-leading DCB, the TRANSCEND trial will answer clinically important questions about the relative performance of DCBs,” said Gary Ansel, M.D., system medical chief of the Vascular Program at OhioHealth. “DCB therapy for patients with lower extremity PAD is growing rapidly, and while results have been encouraging there is significant room for improvement.”
 
The design of the SurVeil DCB reflects Surmodics’ long-standing industry leadership in the development of surface technology for vascular medical devices. The device includes a proprietary drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Pre-clinical data have shown a three to five times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug concentrations compared to control DCBs.1
 
“Surmodics’ expertise and capabilities in surface technology are evident in the design and pre-clinical performance of the SurVeil DCB,” said Kenneth Rosenfield, M.D., section head, Vascular Medicine and Intervention at Massachusetts General Hospital and chair of the Surmodics clinical advisory board. “We’re excited about Surmodics’ capability to improve on the performance of existing DCBs.”
 
The SurVeil DCB early feasibility study (EFS), conducted in the United States, met its primary endpoint by demonstrating peak paclitaxel plasma concentrations post-index procedure. Consistent with pre-clinical data, systemic levels were low and cleared rapidly. No safety issues attributed to the product have been reported.
 
“Surmodics’ decision to pursue the EFS in the U.S. demonstrated our confidence in the device and we are excited to be moving this into the pivotal trial,” said Gary Maharaj, president and CEO of Surmodics. “The next-generation technology in the SurVeil DCB aims to improve drug transfer and effect on the arterial wall with a lower drug dose and a reduction in the amount of drug reaching tissue outside the area of treatment. We have been extremely satisfied with our pre-clinical and EFS results and look forward to working with our investigators in this trial to further evaluate the safety and efficacy compared to standard-of-care DCB therapy.”
 
The development of the SurVeil DCB is a major step forward in Surmodics’ strategy to transform from a surface modification technology company to a provider of whole-product solutions for its medical device customers. In 2015, the company acquired Creagh Medical, an innovative developer and manufacturer of balloon catheters located in Ireland, and U.S.-based NorMedix, a manufacturer of differentiated specialty catheter and device delivery systems. Surmodics now has complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter solutions that utilize the company’s advanced surface technology.
 
The objective of the SurVeil DCB pivotal trial, TRANSCEND, is to evaluate the safety and effectiveness of the device for treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support regulatory approvals (United States and Europe) and reimbursement.
 
The trial will enroll up to 446 subjects at approximately 60 sites in the United States and 18 outside the United States. Study participants will be randomized to receive either treatment with SurVeil DCB or IN.PACT Admiral DCB. The primary efficacy endpoint of the trial is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization (TLR) through 12 months post-index procedure. All randomized subjects will be followed through 36 months post-index procedure. Surmodics expects to initiate enrollment in the TRANSCEND clinical trial in the fourth quarter of calendar 2017.
 
The trial will be led by national co-principal investigators Rosenfield and Ansel. Marianne Brodmann, M.D., substitute head of the Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria, is the European principal investigator.
 
The SurVeil DCB is not available for sale in the United States and is for investigational use only.
 
Worldwide, over 200 million people have PAD,2 a serious and underdiagnosed circulatory condition caused by build-up of arterial plaque, most commonly in the legs. Twelve percent to 20 percent of Americans over 60 years old have PAD.3 PAD increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.4
 
Surmodics develops surface modification technologies for intravascular medical devices and provides chemical components for in-vitro diagnostic tests and microarrays. Following two recent acquisitions of Creagh Medical and NorMedix, the company is executing a key growth strategy for its medical device business by expanding to offer total intravascular product solutions to its medical device customers. The combination of proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities, enables Surmodics to significantly increase the value it offers with highly differentiated intravascular solutions designed and engineered to meet the most demanding requirements. With this focus on offering total solutions, Surmodics’ mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minn.

References
1. Surmodics data on file
2. Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
3. Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
4. National Institutes of Health. What is Peripheral Artery Disease? n.d. Web. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-08-09 11:27:00 [updated_at] => 2017-08-09 11:38:46 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["254132","253342","252805","252392","251098","249633","246596","245205","245023","243461","241062","240267","239928"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 257850 [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":"Medtronic plc","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 153505 [primary_image_old] => [slider_image_id] => 153505 [banner_image] => 0 [title] => IN.PACT Admiral Drug-Coated Balloon Safely, Effectively Addresses PAD Challenges [short_title] => [summary] => Study data show IN.PACT SFA continues to be safe, durable, and efficacious out to four years. [slug] => inpact-admiral-drug-coated-balloon-safely-effectively-addresses-pad-challenges [body] => Medtronic plc data reinforce the durability and safety of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD). The two-year, real-world results from the full clinical cohort of the IN.PACT Global Study and four-year results from the pivotal IN.PACT SFA Study were presented in two late-breaking clinical trial presentations at the Vascular Interventional Advances (VIVA) 2017 conference in Las Vegas, Nev.
 
Professor Thomas Zeller, M.D., director of the Department of Angiology at Universitaets-Herzzentrum, Freiburg-Bad Krozingen, Germany, presented the new, two-year results from the full clinical cohort of the IN.PACT Admiral DCB Global Study. The results are the first two-year, real-world, fully adjudicated DCB data to be presented in a scientific congress, which showed consistent performance in both safety and efficacy for IN.PACT Admiral DCB.
 
The data were calculated using Kaplan-Meier survival estimates and revealed a freedom from clinically-driven target lesion revascularization (CD-TLR) rate of 83.3 percent in a real-world patient cohort with a mean lesion length of 12.09 ± 9.54 cm, 18.0 percent in-stent restenosis lesions, 35.5 percent occluded lesions and 39.9 percent diabetes subjects. Additional safety and effectiveness outcomes also included low rates of thrombosis (4.5 percent), occurrences of major target limb amputation (0.7 percent), and CD-TLR (16.9 percent) within two years.
 
"At two years, the IN.PACT Admiral DCB continues to confirm positive outcomes from the IN.PACT randomized trials, demonstrating efficacy, safety, and durability, despite the complexity of these lesions," said Zeller. "These results also highlight the clinical utility of the IN.PACT Admiral DCB as a primary therapy in treating patients with some of the most challenging PAD cases."
 
The IN.PACT Global Study is the largest and most rigorous real-world evaluation of any peripheral artery intervention ever undertaken. It has enrolled over 1,500 patients across 24 countries, including the 1,406 patients in the full clinical cohort most recently presented, to characterize the performance of the IN.PACT Admiral DCB in treating real-world patients with challenging and complex lesions. The study included adjudication of events by an independent clinical events committee.
 
Dr. Peter Schneider, chief of the vascular therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu also presented the first, four-year data outcomes for a DCB, further demonstrating the safety and efficacy of IN.PACT Admiral DCB in patients with PAD. Of the patients who received a repeat procedure within four years, those in the IN.PACT Admiral DCB group showed that time to reintervention was approximately double that of those in the percutaneous transluminal angioplasty (PTA) group (739.2 ± 384.0 days for IN.PACT Admiral DCB on average versus 302.9 ± 213.0 days for PTA (p<0.001)).
 
Using Kaplan-Meier survival rate estimates, IN.PACT Admiral DCB continued to outperform in freedom from CD-TLR compared to PTA with a 76.8 percent compared to 70.4 in PTA (p= 0.0399). The data also showed the long-term safety benefits of the IN.PACT Admiral DCB, with no major target limb amputations, a low rate of thrombosis, and no major adverse events from years three to four in the IN.PACT Admiral DCB group.
 
"With the IN.PACT Admiral DCB, pre-clinical studies have demonstrated that the drug remains in the tissue for approximately six months. Therefore, at four years, we would expect to see some catch up effect and at least some late progression of atherosclerosis," said Schneider. "However, in the four-year data from IN.PACT SFA, we are still seeing sustained durability and clinical benefit. For patients suffering with this chronic condition, these findings are not only encouraging from a therapeutic perspective, but are also suggestive of improved quality of life, with patients requiring fewer reinterventions over time compared to PTA and leaving future treatment options open."
 
The IN.PACT SFA Trial enrolled 331 patients at 57 sites across Europe and the United States who were randomized to treatment with either the IN.PACT Admiral DCB or PTA. The four-year data includes a total of 284 patients (184 DCB and 103 PTA).
 
"PAD is a chronic condition associated with disease progression and often requires repeat interventions to manage the disease," said Mark Pacyna, vice president and general manager of the Peripheral business in Medtronic's Cardiac & Vascular Group. "In partnership with the clinical community, our objective has been to develop a safe, effective, and sustainable treatment option for these patients. The data presented today reflects this goal and our commitment to timely and transparent data releases. We are excited to see consistency in real-world patients and fewer interventions out to four years, which was statistically significant."
 
The IN.PACT Admiral drug-coated balloon is a primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with superficial femoral artery (SFA) disease. It was the first DCB to have received approval by the U.S. Food and Drug Administration (FDA) for the treatment of in-stent restenosis. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the proven paclitaxel drug, with a unique dose and excipient, is intended to prevent artery narrowing by minimizing scar tissue formation.
 
IN.PACT Admiral DCB received the CE Mark in 2009 to treat PAD and was approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries. It has been studied in more than 20 individual clinical trials demonstrating durable safety and clinical benefits. To date, approximately 200,000 patients have been treated with IN.PACT Admiral DCB. It is the only DCB to have published two-year data from a pivotal randomized trial, as well as the first to have presented three- and four-year data.
 
Medtronic plc, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies. It employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-09-20 11:56:00 [updated_at] => 2017-09-20 12:07:58 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["257227","256750","255518","255490","255134","254979","254271","254132","253906","253621","253342","252805","252097","251939","251098","250462","249633","249385","246596","243723","243461","242014"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 257971 [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":"Shockwave Medical","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 153579 [primary_image_old] => [slider_image_id] => 153579 [banner_image] => 0 [title] => Positive Results Reported From First Study of Lithoplasty System in Calcified Lesions Below the Knee [short_title] => [summary] => Results of DISRUPT BTK Study demonstrate promise for challenging patient population. [slug] => positive-results-reported-from-first-study-of-lithoplasty-system-in-calcified-lesions-below-the-knee [body] => Shockwave Medical, a developer of calcified cardiovascular disease treatments, is reporting positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark.
 
“The results of this study are consistent with findings from previous studies of Lithoplasty, showing a low rate of residual stenosis with minimal complications in a predominantly critical limb ischemic patient population,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria. “These results suggest that the Lithoplasty treatment has the potential to address challenges that calcified stenosis pose below the knee, where calcium is more prevalent and different than above the knee. It can occur deeper in the artery wall, making these lesions more difficult to treat. Treatment failure can pose heightened risks for patients with critical limb ischemia, including higher risks of amputation and death.” DISRUPT BTK, a prospective single arm study, evaluated the use of the Shockwave Medical Lithoplasty System as a treatment for peripheral artery disease (PAD) patients with calcified lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and New Zealand.
 
The study enrolled patients with moderate or severe calcified lesions in below the knee arteries, including 80 percent of patients who were classified as having critical limb ischemia. Acute performance results showed low percent residual stenosis (27 percent) with low vascular complications, including no perforations, distal embolization, reflow complications or abrupt closure and only one grade B dissection. There were no major adverse events including death, myocardial infarction, target limb revascularization or amputation through 30 days.
 
The Lithoplasty System is an innovative therapy designed to treat calcified leg artery blockages with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The technology is now commercially available in both the United States and Europe for the treatment of calcified plaque in peripheral arteries.
 
“Interventional procedures that involve moderate and severe calcium can be complex, unpredictable and costly. The previous DISRUPT PAD Study demonstrated that Lithoplasty addresses many major concerns in the treatment of problematic calcium in femoral and popliteal artery lesions, achieving a high acute gain in vessel diameter with minimal dissections, embolization, perforation or recoil,” said Doug Godshall, CEO of Shockwave Medical. “DISRUPT BTK now gives clinicians encouraging data in a high risk patient population where calcific lesions pose different treatment challenges including the potential for limb loss.”
 
PAD blocks blood flow to the legs and feet, causing significant pain and limited mobility, potentially leading to surgery or even amputation in patients presenting with critical limb ischemia. PAD occurs primarily in the legs, and is caused by the buildup of plaque and calcium within the walls of arteries. Balloon angioplasty, which involves inflating a balloon within the artery at the area of narrowing and expanding the artery to alleviate the blockage, is commonly used to treat PAD. Many patients with critical limb ischemia do not respond well to angioplasty alone with blockages reoccurring in 40 percent of the cases, frequently requiring re-interventions and limb amputation.
 
Shockwave Medical’s Lithoplasty System integrates angioplasty balloon catheter devices with the calcium-disrupting power of sonic pressure waves, known as lithotripsy. Each Lithoplasty catheter incorporates multiple lithotripsy emitters activated with the touch of a button after the integrated balloon is inflated. Once activated, these emitters produce therapeutic sonic pressure waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque inside the vessel wall by creating a series of micro-fractures. When the calcium has been modified, the vessel can be dilated using low pressures, thereby enabling even historically challenging PAD patients to be treated effectively with minimal injury to the vessel.
 
The Peripheral Lithoplasty System is commercially available in both the United States and Europe and is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
 
The devices used in the DISRUPT BTK study are not available or approved for sale in the United States.
 
Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty Technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-09-21 10:51:00 [updated_at] => 2017-09-21 10:59:10 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["254341","253983","253234","253124","252392","249069","247636","247546","246467","244250"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 258877 [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] => 154134 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Surmodics Announces Global Approvals of .014-Inch Low-Profile PTA Balloon Dilation Catheter [short_title] => [summary] => The product received FDA 510(k) and CE Mark clearances. [slug] => surmodics-announces-global-approvals-of-014-inch-low-profile-pta-balloon-dilation-catheter [body] => Surmodics Inc., a provider of medical device and in-vitro diagnostic technologies to the healthcare industry, has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearances for its .014-inch low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for peripheral angioplasty procedures. The company is making this product available for distribution in the coming months.
 
Surmodics .014-inch PTA balloon catheter offers best-in-class deliverability and lesion crossing by leveraging the company’s proprietary Serene hydrophilic coating, unmatched for low friction and particulates.1 The company’s proprietary balloon and catheter technology, combined with Surmodics’ advanced processes, ensures ultra-low tip entry and crossing profile with smooth transitions, to achieve best-in-class product performance.
 
“Surmodics is focused on providing next-generation devices to address the growing need for minimally invasive treatment of peripheral artery disease,” said Gary Maharaj, president and CEO of Surmodics. “We’re confident this highly deliverable, low-profile PTA catheter will provide physicians an effective new tool for accessing and crossing even the most complex peripheral lesions.”
 
The development of the Surmodics .014-inch low-profile PTA catheter is a step forward in the company’s strategy to be a provider of whole-product vascular solutions for its medical device customers. Following acquisitions of Creagh Medical and NorMedix, Surmodics now has complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter and specialty catheter solutions.
 
With a suite of in-house capabilities at its facility in Ballinasloe, Ireland, Surmodics controls every step of the manufacturing process to produce high-quality, reliable balloon catheters under rigorous testing. Surmodics’ portfolio of balloon technologies includes the highest-pressure conventional balloons.1
 
Worldwide, over 200 million people have peripheral artery disease (PAD),2 a serious and underdiagnosed circulatory condition caused by build-up of arterial plaque, most commonly in the legs. Twelve to 20 percent of Americans over 60 years old have PAD.3 PAD increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.4
 
Surmodics is a leader in surface modification technologies for intravascular medical devices and a provider of chemical components for in-vitro diagnostic (IVD) tests and microarrays. Following two recent acquisitions of Creagh Medical and NorMedix, the company is expanding to offer total intravascular product solutions to its medical device customers. The combination of proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities, enables Surmodics to significantly increase the value it offers with highly differentiated intravascular solutions designed and engineered to meet the most demanding requirements. With this focus on offering total solutions, Surmodics’ mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minn. 

References
1. Surmodics data on file
2. Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
3. Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
4. National Institutes of Health. What is Peripheral Artery Disease? n.d. Web. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-10-02 11:26:00 [updated_at] => 2017-10-02 11:34:44 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["258622","257850","255518","255490","254341","254132","253342","249800","249385","245023","243466"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 259149 [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":"Shockwave Medical","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 154320 [primary_image_old] => [slider_image_id] => 154320 [banner_image] => 0 [title] => Positive Results Reported From First Study of Lithoplasty System in Calcified Lesions Below the Knee [short_title] => [summary] => Results of Shockwave Medical's DISRUPT BTK study show promise for challenging patient population. [slug] => positive-results-reported-from-first-study-of-lith [body] => Shockwave Medical, a developer of treatments for calcified cardiovascular disease, is reporting positive results from the DISRUPT BTK study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark.
 
“The results of this study are consistent with findings from previous studies of Lithoplasty, showing a low rate of residual stenosis with minimal complications in a predominantly critical limb ischemic patient population,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria. “These results suggest that the Lithoplasty treatment has the potential to address challenges that calcified stenosis pose below the knee, where calcium is more prevalent and different than above the knee. It can occur deeper in the artery wall, making these lesions more difficult to treat. Treatment failure can pose heightened risks for patients with critical limb ischemia, including higher risks of amputation and death.”
 
DISRUPT BTK, a prospective single arm study, evaluated the use of the Shockwave Medical Lithoplasty System as a treatment for peripheral artery disease (PAD) patients with calcified lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and New Zealand.
 
The study enrolled patients with moderate or severe calcified lesions in below the knee arteries, including 80 percent of patients who were classified as having critical limb ischemia. Acute performance results showed low percent residual stenosis (27 percent) with low vascular complications, including no perforations, distal embolization, reflow complications or abrupt closure and only one grade B dissection. There were no major adverse events including death, myocardial infarction, target limb revascularization or amputation through 30 days.
 
The Lithoplasty System is a therapy designed to treat calcified leg artery blockages with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The technology is now commercially available in both the United States and Europe for the treatment of calcified plaque in peripheral arteries.
 
“Interventional procedures that involve moderate and severe calcium can be complex, unpredictable and costly. The previous DISRUPT PAD study demonstrated that Lithoplasty addresses many major concerns in the treatment of problematic calcium in femoral and popliteal artery lesions, achieving a high acute gain in vessel diameter with minimal dissections, embolization, perforation or recoil,” said Doug Godshall, CEO of Shockwave Medical. “DISRUPT BTK now gives clinicians encouraging data in a high risk patient population where calcific lesions pose different treatment challenges including the potential for limb loss.”
 
PAD blocks blood flow to the legs and feet, causing significant pain and limited mobility, potentially leading to surgery or even amputation in patients presenting with critical limb ischemia. PAD occurs primarily in the legs, and is caused by the buildup of plaque and calcium within the walls of arteries. Balloon angioplasty, which involves inflating a balloon within the artery at the area of narrowing and expanding the artery to alleviate the blockage, is commonly used to treat PAD. Many patients with critical limb ischemia do not respond well to angioplasty alone with blockages reoccurring in 40 percent of the cases, frequently requiring re-interventions and limb amputation.
 
Shockwave Medical’s Lithoplasty System integrates angioplasty balloon catheter devices with the calcium-disrupting power of sonic pressure waves, known as lithotripsy. Each Lithoplasty catheter incorporates multiple lithotripsy emitters activated with the touch of a button after the integrated balloon is inflated. Once activated, these emitters produce therapeutic sonic pressure waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque inside the vessel wall by creating a series of micro-fractures. When the calcium has been modified, the vessel can be dilated using low pressures, thereby enabling even historically challenging PAD patients to be treated effectively with minimal injury to the vessel.
 
The Peripheral Lithoplasty System is commercially available in both the United States and Europe and is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. It is not for use in the coronary or cerebral vasculature.
 
The devices used in the DISRUPT BTK study are not available or approved for sale in the United States.
 
Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty Technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-10-04 10:49:00 [updated_at] => 2017-10-04 10:57:43 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["257971","254341","252392","247636","247546"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 254341 [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] => 151153 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Surmodics Receives IDE Approval to Initiate Pivotal Trial of the SurVeil Drug-Coated Balloon [short_title] => [summary] => SurVeil DCB design includes new proprietary coating for interventional treatment of PAD. [slug] => surmodics-receives-ide-approval-to-initiate-pivotal-trial-of-the-surveil-drug-coated-balloon [body] => Surmodics Inc., a provider of medical device and in-vitro diagnostic technologies, has received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the SurVeil drug-coated balloon (DCB). The randomized trial will evaluate the SurVeil DCB for treatment for peripheral artery disease (PAD) in the upper leg compared to the Medtronic IN.PACT Admiral DCB.
 
The SurVeil DCB pivotal trial will be among the first trials in the United States to compare a next-generation DCB with a commercially-available DCB.
 
“By providing a head-to-head comparison with today’s market-leading DCB, the TRANSCEND trial will answer clinically important questions about the relative performance of DCBs,” said Gary Ansel, M.D., system medical chief of the Vascular Program at OhioHealth. “DCB therapy for patients with lower extremity PAD is growing rapidly, and while results have been encouraging there is significant room for improvement.”
 
The design of the SurVeil DCB reflects Surmodics’ long-standing industry leadership in the development of surface technology for vascular medical devices. The device includes a proprietary drug-excipient formulation for the balloon coating and is manufactured using a proprietary process to improve coating uniformity. Pre-clinical data have shown a three to five times higher target tissue drug concentration, a more evenly distributed and durable drug effect, and lower incidence of downstream drug concentrations compared to control DCBs.1
 
“Surmodics’ expertise and capabilities in surface technology are evident in the design and pre-clinical performance of the SurVeil DCB,” said Kenneth Rosenfield, M.D., section head, Vascular Medicine and Intervention at Massachusetts General Hospital and chair of the Surmodics clinical advisory board. “We’re excited about Surmodics’ capability to improve on the performance of existing DCBs.”
 
The SurVeil DCB early feasibility study (EFS), conducted in the United States, met its primary endpoint by demonstrating peak paclitaxel plasma concentrations post-index procedure. Consistent with pre-clinical data, systemic levels were low and cleared rapidly. No safety issues attributed to the product have been reported.
 
“Surmodics’ decision to pursue the EFS in the U.S. demonstrated our confidence in the device and we are excited to be moving this into the pivotal trial,” said Gary Maharaj, president and CEO of Surmodics. “The next-generation technology in the SurVeil DCB aims to improve drug transfer and effect on the arterial wall with a lower drug dose and a reduction in the amount of drug reaching tissue outside the area of treatment. We have been extremely satisfied with our pre-clinical and EFS results and look forward to working with our investigators in this trial to further evaluate the safety and efficacy compared to standard-of-care DCB therapy.”
 
The development of the SurVeil DCB is a major step forward in Surmodics’ strategy to transform from a surface modification technology company to a provider of whole-product solutions for its medical device customers. In 2015, the company acquired Creagh Medical, an innovative developer and manufacturer of balloon catheters located in Ireland, and U.S.-based NorMedix, a manufacturer of differentiated specialty catheter and device delivery systems. Surmodics now has complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter solutions that utilize the company’s advanced surface technology.
 
The objective of the SurVeil DCB pivotal trial, TRANSCEND, is to evaluate the safety and effectiveness of the device for treatment of subjects with symptomatic PAD due to stenosis of the femoral and/or popliteal arteries. The clinical study will be used to support regulatory approvals (United States and Europe) and reimbursement.
 
The trial will enroll up to 446 subjects at approximately 60 sites in the United States and 18 outside the United States. Study participants will be randomized to receive either treatment with SurVeil DCB or IN.PACT Admiral DCB. The primary efficacy endpoint of the trial is primary patency, defined as a composite of freedom from restenosis and clinically-driven target lesion revascularization (TLR) through 12 months post-index procedure. All randomized subjects will be followed through 36 months post-index procedure. Surmodics expects to initiate enrollment in the TRANSCEND clinical trial in the fourth quarter of calendar 2017.
 
The trial will be led by national co-principal investigators Rosenfield and Ansel. Marianne Brodmann, M.D., substitute head of the Division of Angiology, Department of Internal Medicine, Medical University of Graz, Graz, Austria, is the European principal investigator.
 
The SurVeil DCB is not available for sale in the United States and is for investigational use only.
 
Worldwide, over 200 million people have PAD,2 a serious and underdiagnosed circulatory condition caused by build-up of arterial plaque, most commonly in the legs. Twelve percent to 20 percent of Americans over 60 years old have PAD.3 PAD increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.4
 
Surmodics develops surface modification technologies for intravascular medical devices and provides chemical components for in-vitro diagnostic tests and microarrays. Following two recent acquisitions of Creagh Medical and NorMedix, the company is executing a key growth strategy for its medical device business by expanding to offer total intravascular product solutions to its medical device customers. The combination of proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities, enables Surmodics to significantly increase the value it offers with highly differentiated intravascular solutions designed and engineered to meet the most demanding requirements. With this focus on offering total solutions, Surmodics’ mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minn.

References
1. Surmodics data on file
2. Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
3. Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
4. National Institutes of Health. What is Peripheral Artery Disease? n.d. Web. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-08-09 11:27:00 [updated_at] => 2017-08-09 11:38:46 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["254132","253342","252805","252392","251098","249633","246596","245205","245023","243461","241062","240267","239928"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 257850 [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":"Medtronic plc","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 153505 [primary_image_old] => [slider_image_id] => 153505 [banner_image] => 0 [title] => IN.PACT Admiral Drug-Coated Balloon Safely, Effectively Addresses PAD Challenges [short_title] => [summary] => Study data show IN.PACT SFA continues to be safe, durable, and efficacious out to four years. [slug] => inpact-admiral-drug-coated-balloon-safely-effectively-addresses-pad-challenges [body] => Medtronic plc data reinforce the durability and safety of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral arterial disease (PAD). The two-year, real-world results from the full clinical cohort of the IN.PACT Global Study and four-year results from the pivotal IN.PACT SFA Study were presented in two late-breaking clinical trial presentations at the Vascular Interventional Advances (VIVA) 2017 conference in Las Vegas, Nev.
 
Professor Thomas Zeller, M.D., director of the Department of Angiology at Universitaets-Herzzentrum, Freiburg-Bad Krozingen, Germany, presented the new, two-year results from the full clinical cohort of the IN.PACT Admiral DCB Global Study. The results are the first two-year, real-world, fully adjudicated DCB data to be presented in a scientific congress, which showed consistent performance in both safety and efficacy for IN.PACT Admiral DCB.
 
The data were calculated using Kaplan-Meier survival estimates and revealed a freedom from clinically-driven target lesion revascularization (CD-TLR) rate of 83.3 percent in a real-world patient cohort with a mean lesion length of 12.09 ± 9.54 cm, 18.0 percent in-stent restenosis lesions, 35.5 percent occluded lesions and 39.9 percent diabetes subjects. Additional safety and effectiveness outcomes also included low rates of thrombosis (4.5 percent), occurrences of major target limb amputation (0.7 percent), and CD-TLR (16.9 percent) within two years.
 
"At two years, the IN.PACT Admiral DCB continues to confirm positive outcomes from the IN.PACT randomized trials, demonstrating efficacy, safety, and durability, despite the complexity of these lesions," said Zeller. "These results also highlight the clinical utility of the IN.PACT Admiral DCB as a primary therapy in treating patients with some of the most challenging PAD cases."
 
The IN.PACT Global Study is the largest and most rigorous real-world evaluation of any peripheral artery intervention ever undertaken. It has enrolled over 1,500 patients across 24 countries, including the 1,406 patients in the full clinical cohort most recently presented, to characterize the performance of the IN.PACT Admiral DCB in treating real-world patients with challenging and complex lesions. The study included adjudication of events by an independent clinical events committee.
 
Dr. Peter Schneider, chief of the vascular therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu also presented the first, four-year data outcomes for a DCB, further demonstrating the safety and efficacy of IN.PACT Admiral DCB in patients with PAD. Of the patients who received a repeat procedure within four years, those in the IN.PACT Admiral DCB group showed that time to reintervention was approximately double that of those in the percutaneous transluminal angioplasty (PTA) group (739.2 ± 384.0 days for IN.PACT Admiral DCB on average versus 302.9 ± 213.0 days for PTA (p<0.001)).
 
Using Kaplan-Meier survival rate estimates, IN.PACT Admiral DCB continued to outperform in freedom from CD-TLR compared to PTA with a 76.8 percent compared to 70.4 in PTA (p= 0.0399). The data also showed the long-term safety benefits of the IN.PACT Admiral DCB, with no major target limb amputations, a low rate of thrombosis, and no major adverse events from years three to four in the IN.PACT Admiral DCB group.
 
"With the IN.PACT Admiral DCB, pre-clinical studies have demonstrated that the drug remains in the tissue for approximately six months. Therefore, at four years, we would expect to see some catch up effect and at least some late progression of atherosclerosis," said Schneider. "However, in the four-year data from IN.PACT SFA, we are still seeing sustained durability and clinical benefit. For patients suffering with this chronic condition, these findings are not only encouraging from a therapeutic perspective, but are also suggestive of improved quality of life, with patients requiring fewer reinterventions over time compared to PTA and leaving future treatment options open."
 
The IN.PACT SFA Trial enrolled 331 patients at 57 sites across Europe and the United States who were randomized to treatment with either the IN.PACT Admiral DCB or PTA. The four-year data includes a total of 284 patients (184 DCB and 103 PTA).
 
"PAD is a chronic condition associated with disease progression and often requires repeat interventions to manage the disease," said Mark Pacyna, vice president and general manager of the Peripheral business in Medtronic's Cardiac & Vascular Group. "In partnership with the clinical community, our objective has been to develop a safe, effective, and sustainable treatment option for these patients. The data presented today reflects this goal and our commitment to timely and transparent data releases. We are excited to see consistency in real-world patients and fewer interventions out to four years, which was statistically significant."
 
The IN.PACT Admiral drug-coated balloon is a primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with superficial femoral artery (SFA) disease. It was the first DCB to have received approval by the U.S. Food and Drug Administration (FDA) for the treatment of in-stent restenosis. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the proven paclitaxel drug, with a unique dose and excipient, is intended to prevent artery narrowing by minimizing scar tissue formation.
 
IN.PACT Admiral DCB received the CE Mark in 2009 to treat PAD and was approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries. It has been studied in more than 20 individual clinical trials demonstrating durable safety and clinical benefits. To date, approximately 200,000 patients have been treated with IN.PACT Admiral DCB. It is the only DCB to have published two-year data from a pivotal randomized trial, as well as the first to have presented three- and four-year data.
 
Medtronic plc, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies. It employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-09-20 11:56:00 [updated_at] => 2017-09-20 12:07:58 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["257227","256750","255518","255490","255134","254979","254271","254132","253906","253621","253342","252805","252097","251939","251098","250462","249633","249385","246596","243723","243461","242014"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 257971 [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":"Shockwave Medical","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 153579 [primary_image_old] => [slider_image_id] => 153579 [banner_image] => 0 [title] => Positive Results Reported From First Study of Lithoplasty System in Calcified Lesions Below the Knee [short_title] => [summary] => Results of DISRUPT BTK Study demonstrate promise for challenging patient population. [slug] => positive-results-reported-from-first-study-of-lithoplasty-system-in-calcified-lesions-below-the-knee [body] => Shockwave Medical, a developer of calcified cardiovascular disease treatments, is reporting positive results from the DISRUPT BTK Study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark.
 
“The results of this study are consistent with findings from previous studies of Lithoplasty, showing a low rate of residual stenosis with minimal complications in a predominantly critical limb ischemic patient population,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria. “These results suggest that the Lithoplasty treatment has the potential to address challenges that calcified stenosis pose below the knee, where calcium is more prevalent and different than above the knee. It can occur deeper in the artery wall, making these lesions more difficult to treat. Treatment failure can pose heightened risks for patients with critical limb ischemia, including higher risks of amputation and death.” DISRUPT BTK, a prospective single arm study, evaluated the use of the Shockwave Medical Lithoplasty System as a treatment for peripheral artery disease (PAD) patients with calcified lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and New Zealand.
 
The study enrolled patients with moderate or severe calcified lesions in below the knee arteries, including 80 percent of patients who were classified as having critical limb ischemia. Acute performance results showed low percent residual stenosis (27 percent) with low vascular complications, including no perforations, distal embolization, reflow complications or abrupt closure and only one grade B dissection. There were no major adverse events including death, myocardial infarction, target limb revascularization or amputation through 30 days.
 
The Lithoplasty System is an innovative therapy designed to treat calcified leg artery blockages with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The technology is now commercially available in both the United States and Europe for the treatment of calcified plaque in peripheral arteries.
 
“Interventional procedures that involve moderate and severe calcium can be complex, unpredictable and costly. The previous DISRUPT PAD Study demonstrated that Lithoplasty addresses many major concerns in the treatment of problematic calcium in femoral and popliteal artery lesions, achieving a high acute gain in vessel diameter with minimal dissections, embolization, perforation or recoil,” said Doug Godshall, CEO of Shockwave Medical. “DISRUPT BTK now gives clinicians encouraging data in a high risk patient population where calcific lesions pose different treatment challenges including the potential for limb loss.”
 
PAD blocks blood flow to the legs and feet, causing significant pain and limited mobility, potentially leading to surgery or even amputation in patients presenting with critical limb ischemia. PAD occurs primarily in the legs, and is caused by the buildup of plaque and calcium within the walls of arteries. Balloon angioplasty, which involves inflating a balloon within the artery at the area of narrowing and expanding the artery to alleviate the blockage, is commonly used to treat PAD. Many patients with critical limb ischemia do not respond well to angioplasty alone with blockages reoccurring in 40 percent of the cases, frequently requiring re-interventions and limb amputation.
 
Shockwave Medical’s Lithoplasty System integrates angioplasty balloon catheter devices with the calcium-disrupting power of sonic pressure waves, known as lithotripsy. Each Lithoplasty catheter incorporates multiple lithotripsy emitters activated with the touch of a button after the integrated balloon is inflated. Once activated, these emitters produce therapeutic sonic pressure waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque inside the vessel wall by creating a series of micro-fractures. When the calcium has been modified, the vessel can be dilated using low pressures, thereby enabling even historically challenging PAD patients to be treated effectively with minimal injury to the vessel.
 
The Peripheral Lithoplasty System is commercially available in both the United States and Europe and is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
 
The devices used in the DISRUPT BTK study are not available or approved for sale in the United States.
 
Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty Technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-09-21 10:51:00 [updated_at] => 2017-09-21 10:59:10 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["254341","253983","253234","253124","252392","249069","247636","247546","246467","244250"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 258877 [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] => 154134 [primary_image_old] => [slider_image_id] => [banner_image] => 0 [title] => Surmodics Announces Global Approvals of .014-Inch Low-Profile PTA Balloon Dilation Catheter [short_title] => [summary] => The product received FDA 510(k) and CE Mark clearances. [slug] => surmodics-announces-global-approvals-of-014-inch-low-profile-pta-balloon-dilation-catheter [body] => Surmodics Inc., a provider of medical device and in-vitro diagnostic technologies to the healthcare industry, has received U.S. Food and Drug Administration (FDA) 510(k) and CE Mark clearances for its .014-inch low-profile percutaneous transluminal angioplasty (PTA) balloon dilation catheter, designed for peripheral angioplasty procedures. The company is making this product available for distribution in the coming months.
 
Surmodics .014-inch PTA balloon catheter offers best-in-class deliverability and lesion crossing by leveraging the company’s proprietary Serene hydrophilic coating, unmatched for low friction and particulates.1 The company’s proprietary balloon and catheter technology, combined with Surmodics’ advanced processes, ensures ultra-low tip entry and crossing profile with smooth transitions, to achieve best-in-class product performance.
 
“Surmodics is focused on providing next-generation devices to address the growing need for minimally invasive treatment of peripheral artery disease,” said Gary Maharaj, president and CEO of Surmodics. “We’re confident this highly deliverable, low-profile PTA catheter will provide physicians an effective new tool for accessing and crossing even the most complex peripheral lesions.”
 
The development of the Surmodics .014-inch low-profile PTA catheter is a step forward in the company’s strategy to be a provider of whole-product vascular solutions for its medical device customers. Following acquisitions of Creagh Medical and NorMedix, Surmodics now has complete capabilities for design, development and high-volume manufacturing of a wide variety of highly differentiated balloon catheter and specialty catheter solutions.
 
With a suite of in-house capabilities at its facility in Ballinasloe, Ireland, Surmodics controls every step of the manufacturing process to produce high-quality, reliable balloon catheters under rigorous testing. Surmodics’ portfolio of balloon technologies includes the highest-pressure conventional balloons.1
 
Worldwide, over 200 million people have peripheral artery disease (PAD),2 a serious and underdiagnosed circulatory condition caused by build-up of arterial plaque, most commonly in the legs. Twelve to 20 percent of Americans over 60 years old have PAD.3 PAD increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.4
 
Surmodics is a leader in surface modification technologies for intravascular medical devices and a provider of chemical components for in-vitro diagnostic (IVD) tests and microarrays. Following two recent acquisitions of Creagh Medical and NorMedix, the company is expanding to offer total intravascular product solutions to its medical device customers. The combination of proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities, enables Surmodics to significantly increase the value it offers with highly differentiated intravascular solutions designed and engineered to meet the most demanding requirements. With this focus on offering total solutions, Surmodics’ mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minn. 

References
1. Surmodics data on file
2. Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
3. Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
4. National Institutes of Health. What is Peripheral Artery Disease? n.d. Web. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2017-10-02 11:26:00 [updated_at] => 2017-10-02 11:34:44 [last_updated_author] => 142087 [uploaded_by] => 142087 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["258622","257850","255518","255490","254341","254132","253342","249800","249385","245023","243466"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 259149 [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":"Shockwave Medical","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 154320 [primary_image_old] => [slider_image_id] => 154320 [banner_image] => 0 [title] => Positive Results Reported From First Study of Lithoplasty System in Calcified Lesions Below the Knee [short_title] => [summary] => Results of Shockwave Medical's DISRUPT BTK study show promise for challenging patient population. [slug] => positive-results-reported-from-first-study-of-lith [body] => Shockwave Medical, a developer of treatments for calcified cardiovascular disease, is reporting positive results from the DISRUPT BTK study, which were presented at the annual Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Copenhagen, Denmark.
 
“The results of this study are consistent with findings from previous studies of Lithoplasty, showing a low rate of residual stenosis with minimal complications in a predominantly critical limb ischemic patient population,” said Marianne Brodmann, M.D., of the Medical University of Graz, Austria. “These results suggest that the Lithoplasty treatment has the potential to address challenges that calcified stenosis pose below the knee, where calcium is more prevalent and different than above the knee. It can occur deeper in the artery wall, making these lesions more difficult to treat. Treatment failure can pose heightened risks for patients with critical limb ischemia, including higher risks of amputation and death.”
 
DISRUPT BTK, a prospective single arm study, evaluated the use of the Shockwave Medical Lithoplasty System as a treatment for peripheral artery disease (PAD) patients with calcified lesions in arteries below the knee. The study enrolled 20 patients at three sites in Europe and New Zealand.
 
The study enrolled patients with moderate or severe calcified lesions in below the knee arteries, including 80 percent of patients who were classified as having critical limb ischemia. Acute performance results showed low percent residual stenosis (27 percent) with low vascular complications, including no perforations, distal embolization, reflow complications or abrupt closure and only one grade B dissection. There were no major adverse events including death, myocardial infarction, target limb revascularization or amputation through 30 days.
 
The Lithoplasty System is a therapy designed to treat calcified leg artery blockages with lithotripsy, sonic pressure waves historically used to treat patients with kidney stones. The technology is now commercially available in both the United States and Europe for the treatment of calcified plaque in peripheral arteries.
 
“Interventional procedures that involve moderate and severe calcium can be complex, unpredictable and costly. The previous DISRUPT PAD study demonstrated that Lithoplasty addresses many major concerns in the treatment of problematic calcium in femoral and popliteal artery lesions, achieving a high acute gain in vessel diameter with minimal dissections, embolization, perforation or recoil,” said Doug Godshall, CEO of Shockwave Medical. “DISRUPT BTK now gives clinicians encouraging data in a high risk patient population where calcific lesions pose different treatment challenges including the potential for limb loss.”
 
PAD blocks blood flow to the legs and feet, causing significant pain and limited mobility, potentially leading to surgery or even amputation in patients presenting with critical limb ischemia. PAD occurs primarily in the legs, and is caused by the buildup of plaque and calcium within the walls of arteries. Balloon angioplasty, which involves inflating a balloon within the artery at the area of narrowing and expanding the artery to alleviate the blockage, is commonly used to treat PAD. Many patients with critical limb ischemia do not respond well to angioplasty alone with blockages reoccurring in 40 percent of the cases, frequently requiring re-interventions and limb amputation.
 
Shockwave Medical’s Lithoplasty System integrates angioplasty balloon catheter devices with the calcium-disrupting power of sonic pressure waves, known as lithotripsy. Each Lithoplasty catheter incorporates multiple lithotripsy emitters activated with the touch of a button after the integrated balloon is inflated. Once activated, these emitters produce therapeutic sonic pressure waves that are inherently tissue-selective, passing through the balloon and soft vascular tissue, preferentially disrupting the calcified plaque inside the vessel wall by creating a series of micro-fractures. When the calcium has been modified, the vessel can be dilated using low pressures, thereby enabling even historically challenging PAD patients to be treated effectively with minimal injury to the vessel.
 
The Peripheral Lithoplasty System is commercially available in both the United States and Europe and is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. It is not for use in the coronary or cerebral vasculature.
 
The devices used in the DISRUPT BTK study are not available or approved for sale in the United States.
 
Shockwave Medical, based in Fremont, Calif., is working to reshape interventional therapy with Lithoplasty Technology for the treatment of calcified peripheral vascular, coronary vascular and heart valve disease. 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