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    [title] => Late-Breaking Trial Data Shows Continued Success of Boston Scientific's EMBLEM S-ICD System
    [short_title] => 
    [summary] => New data further supports the use of the S-ICD System as first-line therapy for the majority of ICD patients.
    [slug] => late-breaking-trial-data-shows-continued-success-of-boston-scientifics-emblem-s-icd-system
    [body] => Boston Scientific announced acute results from the UNTOUCHED study evaluating safety and efficacy of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35 percent, the most common population to be indicated for ICD therapy.1,2 The data were presented during a late-breaking clinical trial at Heart Rhythm 2019, the Heart Rhythm Society's 40th Annual Scientific Sessions in San Francisco, and demonstrated S-ICD therapy had a complication-free rate of 95.8 percent at 30 days post-procedure and high conversion efficacy (99.2 percent) of induced ventricular fibrillation, rates comparable to those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies. The analysis was also published online in the Heart Rhythm Journal
 
The UNTOUCHED study authors also reviewed procedure techniques and 30-day outcomes in patients implanted with the EMBLEM S-ICD System and found that the majority (69 percent) of procedures were performed using a two-incision technique. The two-incision technique data demonstrated a mean implant time of 55.8 minutes, which was 8 minutes faster than the mean 63.8 minutes for procedures that leveraged a three-incision implant technique, with comparable complication and conversion success rates.
 
"We found that the complication rate within this primary prevention population was as low as in prior S-ICD registries, despite the patients having much lower LVEF, more hypertension, and diabetes—underscoring that sicker patients do well with this device for the prevention of sudden death," said Lucas V.A. Boersma, M.D., Ph.D., study principal investigator and electrophysiologist at St. Antonius Hospital, the Netherlands. "These acute outcomes also validate the advantages of the two-incision implant technique, which has continued to gain worldwide adoption in the last few years."
 
The global, prospective, non-randomized study evaluated data from 1,116 patients with a low LVEF, the majority of whom (54 percent) had ischemic heart disease.
 
"The data presented today reiterate the value of the EMBLEM S-ICD System for a broad group of ICD-indicated patients, enabling them to avoid the long-term complications associated with TV-ICD leads," said Kenneth Stein, M.D., senior vice president and chief medical officer, Global Health Policy and Rhythm Management, Boston Scientific. "We remain proud of the clinical success of the S-ICD System, which has now been implanted in nearly 60,000 patients worldwide, and we will continue to invest in clinical studies that advance our understanding of the role of the device in patients at risk of sudden cardiac death."
 
The final results of the UNTOUCHED study, including an analysis comparing inappropriate shock rates of the S-ICD to rates found in previous TV-ICD studies, will be reported after 18-months of patient follow-up.   [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-05-13 10:27:00 [updated_at] => 2019-05-13 10:34:17 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["313945","313724","312809","312589","312374","306563","305808","304962","304174","302686","313849","314031","314070","313952","313960","311425","314034","314101","311905","310323"] [is_show_company_name] => [created_at] => 2019-05-13 10:21:23 [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/2019-05-13/late-breaking-trial-data-shows-continued-success-of-boston-scientifics-emblem-s-icd-system/ [relatedArticles] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302686 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178336 [primary_image_old] => [slider_image_id] => 178336 [banner_image] => 0 [title] => Boston Scientific Acquires U.K.-Based BTG for $4.2B [short_title] => [summary] => BTG develops products used in minimally-invasive procedures targeting cancer and vascular diseases. [slug] => boston-scientific-acquires-uk-based-btg-for-42b [body] => Boston Scientific today announced it has reached an agreement on the terms of a recommended offer to acquire BTG plc., a company headquartered in the United Kingdom, which develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases, as well as acute care pharmaceuticals. 
 
The transaction has been unanimously approved by the boards of directors of Boston Scientific and BTG. Under the terms of the transaction, holders of BTG's common shares would receive cash consideration of 840 pence per share. The total cash consideration for 100 percent of BTG's equity is approximately £3.3B, or U.S.$4.2B. The transaction is intended to be effected by way of an English court-sanctioned scheme of arrangement and is expected to close in the first half of 2019, subject to receipt of required regulatory approvals and the approval of BTG's shareholders and the U.K. court.
 
BTG has three key businesses, the largest of which is its Interventional Medicine portfolio which encompasses several peripheral interventional product lines. The interventional oncology franchise includes the TheraSphere Y-90 radiotherapy microspheres and the GALIL cryoablation system, used to treat patients with liver, kidney and other cancers. More than 840,000 people are expected to be diagnosed with liver cancer in 2018, and that number is expected to grow to 1.1 million by 2030.1 Kidney cancer is among the 10 most common cancers in both men and women.2
 
The company's Interventional Medicine business also has a highly-differentiated vascular portfolio, including filters, crossing catheters, microfoam, and the EKOS Endovascular System. The EKOS system, in combination with clot-dissolving drugs, breaks down blood clots to restore blood flow in patients with pulmonary emboli, deep vein thrombosis, and peripheral arterial occlusions. It was the first device cleared by the Food and Drug Administration for the treatment of pulmonary embolism—a common complication of hospitalization and a leading cause of preventable hospital deaths.3
 
"The acquisition of BTG and its rapidly growing peripheral interventional portfolio is an exciting extension of our category leadership strategy that will augment our capabilities in important areas of unmet need such as cancer and pulmonary embolism," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We are confident that the addition of these therapies to our portfolio will ultimately advance patient care in ways that could not be realized by either company alone, while also allowing us to realize substantial revenue and cost synergies and provide a strong return for investors."
 
The BTG portfolio also includes a pharmaceutical business comprised of acute care antidotes to treat overexposure to certain medications and toxins, and a licensing business that receives royalties relating to products subject to BTG intellectual property and license agreements. The company has 1,600 employees globally, located in North America, Europe, Asia, and Australia.  
 
"Boston Scientific shares our commitment to transforming patient care, and has a sustained track record of innovation, clinical expertise, and global commercial capabilities," said Dame Louise Makin, chief executive officer, BTG. "The combined organization will be well positioned for success, enabling our valuable products to make a real difference to more people around the world."
 
Boston Scientific has received irrevocable undertakings to vote in favor of the transaction from BTG's three largest shareholders, covering an aggregate of approximately 33 percent of BTG's outstanding shares, as well as from all of BTG's directors, who hold an additional 0.3 percent of BTG shares. The transaction would be funded with a combination of cash on hand and proceeds from debt financing entered into by Boston Scientific. The full terms of the proposed transaction, including the full terms of the undertakings from BTG's shareholders and directors, are set forth in an announcement made by Boston Scientific, Bravo Bidco Limited, a wholly-owned Boston Scientific subsidiary formed to effect the proposed transaction, and BTG today in accordance with Rule 2.7 of the U.K.'s City Code on Takeovers and Mergers. Boston Scientific has entered into a bridge financing facility providing for its receipt of £3.3B of committed financing, which satisfies the certain funds requirements of the U.K. Takeover Code.
 
The transaction is expected to be two to three cents accretive to Boston Scientific adjusted earnings per share in 2019, and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be dilutive in 2019, and less dilutive or increasingly accretive thereafter, as the case may be, due to amortization expense and acquisition-related net charges.
 
Barclays and Shearman & Sterling are acting as financial and legal advisors, respectively, on behalf of Boston Scientific. 
 
References
1 International Association of Cancer Registries; GLOBOCAN Database: http://gco.iarc.fr/.
2 American Cancer Society. Key Statistics about Kidney Cancer. https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html.
3 American Thoracic Society. Breathing in America: Diseases, Progress and Hope; Chapter 16. https://www.thoracic.org/patients/patient-resources/breathing-in-america/resources/chapter-16-pulmonary-embolism.pdf . [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-20 13:27:00 [updated_at] => 2018-11-20 13:39:53 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["298784","296561","291566","289730","282075","289770","299795","282690","289756","299803","296997","282822","289348","293290","292170","289951","287545","282833","289751","299868"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304174 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179521 [primary_image_old] => [slider_image_id] => 179521 [banner_image] => 0 [title] => Boston Scientific Wins U.S. Edwards TAVR Patent Dispute [short_title] => [summary] => Edwards owes Boston Scientific infringement damages through the end of 2016. [slug] => boston-scientific-wins-us-edwards-tavr-patent-dispute [body] => Boston Scientific Corporation announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences' Sapien 3 Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages through the end of 2016. Additional damages and interest incurred from 2017-2018 will be determined by the court in post-trial motions.
 
The jury also found that the Boston Scientific LOTUS Aortic Valve System does not infringe Edwards' Spenser patents U.S. 7,510,575, U.S. 9,168,133, or U.S. 9,339,383.
 
"We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the U.S., which upholds our company's intellectual property," said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific.
 
The LOTUS system features an adaptive sealing technology, which creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality. The company anticipates the LOTUS Edge Valve System will be commercialized in CE mark countries in Q1 2019 and in the U.S. in mid-2019, pending FDA regulatory approval timelines.
 
The LOTUS valve is one of two valve systems in the Boston Scientific structural heart portfolio. Boston Scientific currently offers the ACURATE neo Aortic Valve System in key European markets and is also seeking a CE mark application for the next-generation valve system, the ACURATE neo2, which it intends to commercialize during the first half of 2019.
 
The LOTUS Edge Aortic valve system is an investigational device in the U.S. and is not available for sale. It is pending CE mark. The ACURATE neo and ACURATE neo2 Aortic Valve Systems are not available for use or sale in the US. The LOTUS Valve System is currently not available for use or sale. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-13 08:19:00 [updated_at] => 2018-12-13 08:29:18 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302686","298784","296561","291566","289730","289770","299795","289756","299803","289791","303994","300637","294049","299790","289744","285583","299797"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304962 [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] => 180081 [primary_image_old] => [slider_image_id] => 180081 [banner_image] => 0 [title] => Boston Scientific Buys Millipede for $325M [short_title] => [summary] => Acquisition will expand structural heart portfolio to include transcatheter mitral annuloplasty repair system. [slug] => boston-scientific-buys-millipede-for-325m [body] => Boston Scientific Corporation announced it exercised its option to acquire the remaining shares of Millipede Inc., a privately-held company in Santa Rosa, Calif., upon its recent successful completion of a first-in-human clinical study. The acquisition will expand the Boston Scientific Structural Heart portfolio to include the IRIS Transcatheter Annuloplasty Ring System which is in development for the treatment of patients with severe mitral regurgitation (MR) who are not able to tolerate open-heart surgery.
 
Boston Scientific initially entered into an investment and acquisition option agreement with Millipede in January 2018. It purchased $90M in existing and newly-issued Millipede shares, with the option to acquire the company's remaining shares for $325M at closing, with a $125M payment becoming available upon achievement of a commercial milestone.
The quickly expanding transcatheter mitral repair and replacement market is estimated to reach $1 billion by 2021, with the majority comprised of repair procedures.
 
"Upon commercialization, we believe the IRIS system can meet the needs of a currently underserved patient population that requires physiological, less invasive options to treat functional mitral regurgitation in patients with progressive heart failure," said Professor Ian Meredith, AM, executive vice president and global chief medical officer, Boston Scientific. "This device is designed to be highly customizable to a specific patient's mitral anatomy and disease state, and is repositionable and retrievable to promote a high-quality outcome."
 
The IRIS system uses a complete annuloplasty ring, considered the gold-standard surgical approach, to reduce the size of a dilated mitral annulus. It is delivered via a transcatheter-transseptal delivery system and can be used as a stand-alone device, or in combination with other technologies in patients with severe MR.
 
"We are very satisfied with the early results of our clinical program and are excited to see this technology further leveraged by Boston Scientific to expand the mitral repair solutions for patients around the world," said Randy Lashinski, co-founder and CEO, Millipede Inc.
 
On an adjusted basis, the transaction is expected to be dilutive to earnings per share (EPS) for each of the next several years; however, all dilutive impact is expected to be absorbed via internal trade-offs, resulting in no net adjusted EPS impact. The deal is anticipated to close in Q1 2019, subject to customary closing conditions. On a GAAP basis, for each of the next several years, the transaction is expected to be more dilutive, due to amortization expense and acquisition-related net charges. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-02 10:41:00 [updated_at] => 2019-01-02 10:49:55 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304174","302686","298784","296561","291566","289730","289770","299795","289756","299803","299650","290582","289757","300702","304464","28717","290175","300637","289720"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 305808 [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] => 180833 [primary_image_old] => [slider_image_id] => 180833 [banner_image] => 0 [title] => Boston Scientific & Edwards Settle Global Patent Litigation [short_title] => [summary] => All patent litigation between the companies to be dismissed; Edwards made a one-time $180 million payment to Boston Scientific. [slug] => boston-scientific-edwards-settle-global-patent-litigation [body] => Boston Scientific Corporation and Edwards Lifesciences Corporation today announced that the companies have reached an agreement to settle all outstanding patent disputes between the companies in all venues around the world. All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted.
 
Under the terms of the agreement, Edwards has made a one-time payment to Boston Scientific of $180 million. No further royalties will be owed by either party under the agreement. All other terms remain confidential.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-15 09:46:00 [updated_at] => 2019-01-15 09:59:16 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304962","304174","302686","298784","296561","291566","289730","289770","299795","289756","299790","289744","299797","303994","289791","300637","294049"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306563 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181639 [primary_image_old] => [slider_image_id] => 181641 [banner_image] => 0 [title] => Boston Scientific Launches Two Deep Brain Stimulation Systems with Directional Leads [short_title] => [summary] => Advanced systems offer customizable therapy addressing progression of Parkinson’s disease. [slug] => boston-scientific-launches-two-deep-brain-stimulation-systems-with-directional-leads [body] => Boston Scientific Corporation has launched the Vercise Primary Cell (PC) and Vercise Gevia Deep Brain Stimulation (DBS) Systems featuring the Vercise Cartesia Directional Lead. The new systems, which were recently approved by the U.S. Food and Drug Administration (FDA), feature technology designed to allow physicians to control the range, shape, position, and direction of electrical stimulation to treat the symptoms of Parkinson’s disease (PD) through highly-personalized therapy. The Vercise Cartesia Directional Lead was the first directional lead introduced to the global market when it launched in Europe in 2015.
 
More than 10 million people worldwide are living with PD—a neurodegenerative disorder which causes stiffness, slowness, and tremors due to the decrease in dopamine production in the brain.1,2 DBS therapy is delivered through leads implanted into a small area of the brain that are powered by an implantable pulse generator (IPG) to send mild electrical stimulation to targeted regions. The new systems featuring the Vercise Cartesia Directional Lead leverage eight individually controlled electrodes on each lead to offer stimulation that can adapt to impedance changes within the brain. This level of precise stimulation to the neural target is critical for avoiding unwanted side effects and obtaining optimal DBS outcomes.
 
“The progression of Parkinson’s disease necessitates a therapy that can evolve with the patient over time,” said Dr. Francisco Ponce, M.D., director of the Barrow Center of Neuromodulation in Phoenix, Arizona and the first center to implant the new system. “The newly approved Vercise Directional DBS Systems offer smaller devices, are engineered for longer rechargeable battery life and more customizable stimulation compared to other similar systems currently in the market. These factors may improve patient comfort and allow physicians to adjust treatment as a patient’s needs change.”


The Vercise Cartesia Directional Lead.
 
The Vercise Gevia DBS System is a rechargeable system with a battery life of at least 15 years and the non-rechargeable Vercise PC DBS System, which offers the same stimulation capability, has a projected battery longevity of at least three years with typical settings. The new systems are supported by programming software with STIMVIEW technology, enabling a physician to visualize how the stimulation used in DBS therapy will be distributed in the brain.
 
“We’re committed to equipping physicians with technology that can improve the lives of patients as their disease progresses,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “Our newest generation Vercise Directional DBS Systems are supported by years of clinical data and real-world experience on the advantages of directionality and offer programming software with features that give physicians the ability to tailor therapy for individual patient needs.”
 
The first Boston Scientific Vercise System in the U.S. was approved by the FDA in December 2017. Clinical evidence of the effectiveness of the Vercise portfolio includes the INTREPID study, the first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for PD in the U.S. Data from the INTREPID study demonstrated that patients treated with the Vercise System had a 49.2 percent improvement in motor symptoms as measured by clinicians in the Unified Parkinson’s Disease Rating Scale (UPDRS) III scores at one year follow-up (n=152).
 
The Vercise Directional DBS Systems are currently being utilized in several clinical studies including the global DBS post-market registry and DIRECT-DBS, which is designed to evaluate programming effectiveness of directional leads for the treatment of Parkinson’s disease.
 
References
1 http://parkinson.org/Understanding-Parkinsons/Causes-and-Statistics/Statistics 
2 https://www.medicinenet.com/parkinsons_disease/article.htm [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-25 10:13:00 [updated_at] => 2019-01-25 10:23:43 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["305808","304962","304174","302686","300329","298784","296561","291566","291206","299795","306356","305313","302016","300250","302305","302922","296562","304399","303313","299802"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) ) [relatedContent] => Array ( [0] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 302686 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 178336 [primary_image_old] => [slider_image_id] => 178336 [banner_image] => 0 [title] => Boston Scientific Acquires U.K.-Based BTG for $4.2B [short_title] => [summary] => BTG develops products used in minimally-invasive procedures targeting cancer and vascular diseases. [slug] => boston-scientific-acquires-uk-based-btg-for-42b [body] => Boston Scientific today announced it has reached an agreement on the terms of a recommended offer to acquire BTG plc., a company headquartered in the United Kingdom, which develops and commercializes products used in minimally-invasive procedures targeting cancer and vascular diseases, as well as acute care pharmaceuticals. 
 
The transaction has been unanimously approved by the boards of directors of Boston Scientific and BTG. Under the terms of the transaction, holders of BTG's common shares would receive cash consideration of 840 pence per share. The total cash consideration for 100 percent of BTG's equity is approximately £3.3B, or U.S.$4.2B. The transaction is intended to be effected by way of an English court-sanctioned scheme of arrangement and is expected to close in the first half of 2019, subject to receipt of required regulatory approvals and the approval of BTG's shareholders and the U.K. court.
 
BTG has three key businesses, the largest of which is its Interventional Medicine portfolio which encompasses several peripheral interventional product lines. The interventional oncology franchise includes the TheraSphere Y-90 radiotherapy microspheres and the GALIL cryoablation system, used to treat patients with liver, kidney and other cancers. More than 840,000 people are expected to be diagnosed with liver cancer in 2018, and that number is expected to grow to 1.1 million by 2030.1 Kidney cancer is among the 10 most common cancers in both men and women.2
 
The company's Interventional Medicine business also has a highly-differentiated vascular portfolio, including filters, crossing catheters, microfoam, and the EKOS Endovascular System. The EKOS system, in combination with clot-dissolving drugs, breaks down blood clots to restore blood flow in patients with pulmonary emboli, deep vein thrombosis, and peripheral arterial occlusions. It was the first device cleared by the Food and Drug Administration for the treatment of pulmonary embolism—a common complication of hospitalization and a leading cause of preventable hospital deaths.3
 
"The acquisition of BTG and its rapidly growing peripheral interventional portfolio is an exciting extension of our category leadership strategy that will augment our capabilities in important areas of unmet need such as cancer and pulmonary embolism," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We are confident that the addition of these therapies to our portfolio will ultimately advance patient care in ways that could not be realized by either company alone, while also allowing us to realize substantial revenue and cost synergies and provide a strong return for investors."
 
The BTG portfolio also includes a pharmaceutical business comprised of acute care antidotes to treat overexposure to certain medications and toxins, and a licensing business that receives royalties relating to products subject to BTG intellectual property and license agreements. The company has 1,600 employees globally, located in North America, Europe, Asia, and Australia.  
 
"Boston Scientific shares our commitment to transforming patient care, and has a sustained track record of innovation, clinical expertise, and global commercial capabilities," said Dame Louise Makin, chief executive officer, BTG. "The combined organization will be well positioned for success, enabling our valuable products to make a real difference to more people around the world."
 
Boston Scientific has received irrevocable undertakings to vote in favor of the transaction from BTG's three largest shareholders, covering an aggregate of approximately 33 percent of BTG's outstanding shares, as well as from all of BTG's directors, who hold an additional 0.3 percent of BTG shares. The transaction would be funded with a combination of cash on hand and proceeds from debt financing entered into by Boston Scientific. The full terms of the proposed transaction, including the full terms of the undertakings from BTG's shareholders and directors, are set forth in an announcement made by Boston Scientific, Bravo Bidco Limited, a wholly-owned Boston Scientific subsidiary formed to effect the proposed transaction, and BTG today in accordance with Rule 2.7 of the U.K.'s City Code on Takeovers and Mergers. Boston Scientific has entered into a bridge financing facility providing for its receipt of £3.3B of committed financing, which satisfies the certain funds requirements of the U.K. Takeover Code.
 
The transaction is expected to be two to three cents accretive to Boston Scientific adjusted earnings per share in 2019, and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be dilutive in 2019, and less dilutive or increasingly accretive thereafter, as the case may be, due to amortization expense and acquisition-related net charges.
 
Barclays and Shearman & Sterling are acting as financial and legal advisors, respectively, on behalf of Boston Scientific. 
 
References
1 International Association of Cancer Registries; GLOBOCAN Database: http://gco.iarc.fr/.
2 American Cancer Society. Key Statistics about Kidney Cancer. https://www.cancer.org/cancer/kidney-cancer/about/key-statistics.html.
3 American Thoracic Society. Breathing in America: Diseases, Progress and Hope; Chapter 16. https://www.thoracic.org/patients/patient-resources/breathing-in-america/resources/chapter-16-pulmonary-embolism.pdf . [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-11-20 13:27:00 [updated_at] => 2018-11-20 13:39:53 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["298784","296561","291566","289730","282075","289770","299795","282690","289756","299803","296997","282822","289348","293290","292170","289951","287545","282833","289751","299868"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [1] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304174 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 179521 [primary_image_old] => [slider_image_id] => 179521 [banner_image] => 0 [title] => Boston Scientific Wins U.S. Edwards TAVR Patent Dispute [short_title] => [summary] => Edwards owes Boston Scientific infringement damages through the end of 2016. [slug] => boston-scientific-wins-us-edwards-tavr-patent-dispute [body] => Boston Scientific Corporation announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences' Sapien 3 Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages through the end of 2016. Additional damages and interest incurred from 2017-2018 will be determined by the court in post-trial motions.
 
The jury also found that the Boston Scientific LOTUS Aortic Valve System does not infringe Edwards' Spenser patents U.S. 7,510,575, U.S. 9,168,133, or U.S. 9,339,383.
 
"We continue to be encouraged by the sustained record of positive legal rulings, first in European courts and now in the U.S., which upholds our company's intellectual property," said Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary, Boston Scientific.
 
The LOTUS system features an adaptive sealing technology, which creates an external seal to prevent leakage around the valve known as paravalvular leak or PVL, which is a proven predictor of mortality. The company anticipates the LOTUS Edge Valve System will be commercialized in CE mark countries in Q1 2019 and in the U.S. in mid-2019, pending FDA regulatory approval timelines.
 
The LOTUS valve is one of two valve systems in the Boston Scientific structural heart portfolio. Boston Scientific currently offers the ACURATE neo Aortic Valve System in key European markets and is also seeking a CE mark application for the next-generation valve system, the ACURATE neo2, which it intends to commercialize during the first half of 2019.
 
The LOTUS Edge Aortic valve system is an investigational device in the U.S. and is not available for sale. It is pending CE mark. The ACURATE neo and ACURATE neo2 Aortic Valve Systems are not available for use or sale in the US. The LOTUS Valve System is currently not available for use or sale. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2018-12-13 08:19:00 [updated_at] => 2018-12-13 08:29:18 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["302686","298784","296561","291566","289730","289770","299795","289756","299803","289791","303994","300637","294049","299790","289744","285583","299797"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [2] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 304962 [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] => 180081 [primary_image_old] => [slider_image_id] => 180081 [banner_image] => 0 [title] => Boston Scientific Buys Millipede for $325M [short_title] => [summary] => Acquisition will expand structural heart portfolio to include transcatheter mitral annuloplasty repair system. [slug] => boston-scientific-buys-millipede-for-325m [body] => Boston Scientific Corporation announced it exercised its option to acquire the remaining shares of Millipede Inc., a privately-held company in Santa Rosa, Calif., upon its recent successful completion of a first-in-human clinical study. The acquisition will expand the Boston Scientific Structural Heart portfolio to include the IRIS Transcatheter Annuloplasty Ring System which is in development for the treatment of patients with severe mitral regurgitation (MR) who are not able to tolerate open-heart surgery.
 
Boston Scientific initially entered into an investment and acquisition option agreement with Millipede in January 2018. It purchased $90M in existing and newly-issued Millipede shares, with the option to acquire the company's remaining shares for $325M at closing, with a $125M payment becoming available upon achievement of a commercial milestone.
The quickly expanding transcatheter mitral repair and replacement market is estimated to reach $1 billion by 2021, with the majority comprised of repair procedures.
 
"Upon commercialization, we believe the IRIS system can meet the needs of a currently underserved patient population that requires physiological, less invasive options to treat functional mitral regurgitation in patients with progressive heart failure," said Professor Ian Meredith, AM, executive vice president and global chief medical officer, Boston Scientific. "This device is designed to be highly customizable to a specific patient's mitral anatomy and disease state, and is repositionable and retrievable to promote a high-quality outcome."
 
The IRIS system uses a complete annuloplasty ring, considered the gold-standard surgical approach, to reduce the size of a dilated mitral annulus. It is delivered via a transcatheter-transseptal delivery system and can be used as a stand-alone device, or in combination with other technologies in patients with severe MR.
 
"We are very satisfied with the early results of our clinical program and are excited to see this technology further leveraged by Boston Scientific to expand the mitral repair solutions for patients around the world," said Randy Lashinski, co-founder and CEO, Millipede Inc.
 
On an adjusted basis, the transaction is expected to be dilutive to earnings per share (EPS) for each of the next several years; however, all dilutive impact is expected to be absorbed via internal trade-offs, resulting in no net adjusted EPS impact. The deal is anticipated to close in Q1 2019, subject to customary closing conditions. On a GAAP basis, for each of the next several years, the transaction is expected to be more dilutive, due to amortization expense and acquisition-related net charges. [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-02 10:41:00 [updated_at] => 2019-01-02 10:49:55 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304174","302686","298784","296561","291566","289730","289770","299795","289756","299803","299650","290582","289757","300702","304464","28717","290175","300637","289720"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [3] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 305808 [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] => 180833 [primary_image_old] => [slider_image_id] => 180833 [banner_image] => 0 [title] => Boston Scientific & Edwards Settle Global Patent Litigation [short_title] => [summary] => All patent litigation between the companies to be dismissed; Edwards made a one-time $180 million payment to Boston Scientific. [slug] => boston-scientific-edwards-settle-global-patent-litigation [body] => Boston Scientific Corporation and Edwards Lifesciences Corporation today announced that the companies have reached an agreement to settle all outstanding patent disputes between the companies in all venues around the world. All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted.
 
Under the terms of the agreement, Edwards has made a one-time payment to Boston Scientific of $180 million. No further royalties will be owed by either party under the agreement. All other terms remain confidential.  [views] => 0 [published] => 1 [status] => 3 [priority] => 0 [publish_date] => 2019-01-15 09:46:00 [updated_at] => 2019-01-15 09:59:16 [last_updated_author] => 199474 [uploaded_by] => 199474 [user_role_id] => 0 [custom_fields] => [] [custom_fields_old] => [splitcontent] => 1 [content_url] => [related_content_ids] => ["304962","304174","302686","298784","296561","291566","289730","289770","299795","289756","299790","289744","299797","303994","289791","300637","294049"] [is_show_company_name] => [created_at] => 2019-04-09 04:36:23 ) [4] => Content Object ( [className] => Content [contentLinks] => Array ( ) [belongsTo] => [contentIssue] => [id] => 306563 [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":"Boston Scientific","title":""} [magazine_id] => 6 [layout_id] => 0 [primary_image] => 181639 [primary_image_old] => [slider_image_id] => 181641 [banner_image] => 0 [title] => Boston Scientific Launches Two Deep Brain Stimulation Systems with Directional Leads [short_title] => [summary] => Advanced systems offer customizable therapy addressing progression of Parkinson’s disease. [slug] => boston-scientific-launches-two-deep-brain-stimulation-systems-with-directional-leads [body] => Boston Scientific Corporation has launched the Vercise Primary Cell (PC) and Vercise Gevia Deep Brain Stimulation (DBS) Systems featuring the Vercise Cartesia Directional Lead. The new systems, which were recently approved by the U.S. Food and Drug Administration (FDA), feature technology designed to allow physicians to control the range, shape, position, and direction of electrical stimulation to treat the symptoms of Parkinson’s disease (PD) through highly-personalized therapy. The Vercise Cartesia Directional Lead was the first directional lead introduced to the global market when it launched in Europe in 2015.
 
More than 10 million people worldwide are living with PD—a neurodegenerative disorder which causes stiffness, slowness, and tremors due to the decrease in dopamine production in the brain.1,2 DBS therapy is delivered through leads implanted into a small area of the brain that are powered by an implantable pulse generator (IPG) to send mild electrical stimulation to targeted regions. The new systems featuring the Vercise Cartesia Directional Lead leverage eight individually controlled electrodes on each lead to offer stimulation that can adapt to impedance changes within the brain. This level of precise stimulation to the neural target is critical for avoiding unwanted side effects and obtaining optimal DBS outcomes.
 
“The progression of Parkinson’s disease necessitates a therapy that can evolve with the patient over time,” said Dr. Francisco Ponce, M.D., director of the Barrow Center of Neuromodulation in Phoenix, Arizona and the first center to implant the new system. “The newly approved Vercise Directional DBS Systems offer smaller devices, are engineered for longer rechargeable battery life and more customizable stimulation compared to other similar systems currently in the market. These factors may improve patient comfort and allow physicians to adjust treatment as a patient’s needs change.”


The Vercise Cartesia Directional Lead.
 
The Vercise Gevia DBS System is a rechargeable system with a battery life of at least 15 years and the non-rechargeable Vercise PC DBS System, which offers the same stimulation capability, has a projected battery longevity of at least three years with typical settings. The new systems are supported by programming software with STIMVIEW technology, enabling a physician to visualize how the stimulation used in DBS therapy will be distributed in the brain.
 
“We’re committed to equipping physicians with technology that can improve the lives of patients as their disease progresses,” said Maulik Nanavaty, senior vice president and president, Neuromodulation, Boston Scientific. “Our newest generation Vercise Directional DBS Systems are supported by years of clinical data and real-world experience on the advantages of directionality and offer programming software with features that give physicians the ability to tailor therapy for individual patient needs.”
 
The first Boston Scientific Vercise System in the U.S. was approved by the FDA in December 2017. Clinical evidence of the effectiveness of the Vercise portfolio includes the INTREPID study, the first multi-center, prospective, double-blind, randomized sham-controlled study of DBS for PD in the U.S. Data from the INTREPID study demonstrated that patients treated with the Vercise System had a 49.2 percent improvement in motor symptoms as measured by clinicians in the Unified Parkinson’s Disease Rating Scale (UPDRS) III scores at one year follow-up (n=152).
 
The Vercise Directional DBS Systems are currently being utilized in several clinical studies including the global DBS post-market registry and DIRECT-DBS, which is designed to evaluate programming effectiveness of directional leads for the treatment of Parkinson’s disease.
 
References
1 http://parkinson.org/Understanding-Parkinsons/Causes-and-Statistics/Statistics 
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