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MassDevice.com +3 | The top 3 medtech stories for November 24, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
3. Ocular Therapeutix launches another pivotal for Dextenza eye drug-device combo
Ocular Therapeutix said today that it launched another pivotal trial for its Dextenza drug-device combination, its 2nd study of the treatment for an allergic conjunctivitis indication.
Bedford, Mass.-based Ocular Th...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Study: 3D MRI reveals early stroke risk in diabetics
A new study suggests that diabetes patients may be at a higher risk for stroke due to harboring advanced vascular disease, and that arterial imaging with 3D MRI could help determine stroke risk in diabetes patients.
Data from the study is slated to be presented at the Radiological Society of North America’s annual meeting next week.
“A recent analysis of multiple studies has shown that people with carotid artery narrowing and IPH have a 5- to 6-times higher risk of stroke in the near future compared to people without,” study author Dr. Tishan Maraj of Sunnybrook Research Institute said in prepared remark...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Diabetes Vascular Radiological Society of North America Source Type: news
Report: Medicare proposal would broaden coverage for Boston Scientific’s Watchman
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified official with the federal health insurer.
Leerink Partners analyst Danielle Antalffy, citing a Bloomberg report, wrote today that the CMS official “clarified that CMS is proposing to pay for Watchman for a subset of the patients who currently would be eligible for the device under the FDA-approved label,” or patients at high risk for stroke and bleeding and/or contraindicated to long-term warfarin use.
“Whi...
Source: Mass Device - November 24, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Source Type: news
Analysts: Worst case unlikely in Medicare call on Boston Scientific’s Watchman anti-stroke device
The worst-case Medicare reimbursement scenario for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device is unlikely to play out, according to a pair of analysts.
Boston Scientific shares took a hit earlier this month after the Centers for Medicare & Medicaid Services proposed to limit coverage for the Watchman device, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke. The FDA approved Watchman in March.
The federal health insurer proposed to limit coverage for Watchman to patients in approved clinical trials who can&#...
Source: Mass Device - November 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Wall Street Beat Boston Scientific Centers for Medicare and Medicaid Services (CMS) Reimbursement Stroke Source Type: news
Boston Scientific dips on Medicare reimbursement hit for Watchman anti-stroke device
Boston Scientific (NYSE:BSX) shares took a hit yesterday after a Centers for Medicare & Medicaid Services proposal that would limit coverage for the Watchman anti-stroke device. Investors also likely reacted to a pair of Class II recalls from the FDA, sending BSX shares down -4.2% to $18.01 apiece yesterday.
Watchman, a transcatheter implant designed to seal off the left atrial appendage to prevent the formation of blood clots that could cause stroke, was approved by the FDA in March and asked for a CMS coverage decision in May. The federal health insurer proposed to limit coverage for Watchman to patients in approv...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Recalls Boston Scientific Cardiac Rhythm Management Stroke Source Type: news
Boston Scientific touts Watchman study data
Boston Scientific (NYSE:BSX) yesterday presented data on its Watchman left atrial appendage occlusion device. The data was presented at the annual American Heart Association’s Scientific Sessions in Orlando, Fla.
The data comes from the Ewolution registry, the 1st real-world study of the Marlborough, Mass.-based company’s Watchman device.
The patient population of the study was the ‘highest risk patient population ever studied in a Watchman trial,” Boston Scientific said. A total 61.8% of the patient population were deemed contraindicated for oral anticoagulants.
The study reported the lowest peri-...
Source: Mass Device - November 10, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Boston Scientific Source Type: news
Neuravi launches clinical trial of Embotrap stent retriever
Neuravi said today it enrolled the 1st patient in a clinical trial of its novel EmboTrap revascularization stent retriever device for treating acute ischemic stroke.
Data from the study will be submitted as part of Neuravi’s FDA premarket approval application, the Ireland-based company said.
“Working to improve clinical outcomes in stroke is central to Neuravi’s mission, and we are committed to investing in clinical research in order to deliver advanced technologies and new clinical tools to physicians. We are honored to be working with an esteemed group of global leaders in stroke treatment as part of the A...
Source: Mass Device - November 5, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Surgical Vascular Neuravi Limited Source Type: news
Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news
Procyrion’s Aortix device could heighten heart pump competition
Pay attention to Procyrion over the next several months. CEO Benjamin Hertzog tells MassDevice.com that the company plans on heading to the clinic with a device that could heighten competition among makers of cardiac assist devices.
The Houston-based startup plans to begin 1st-in-human trials of its Aortix catheter-based heart pump in the 1st half of 2016.
Other companies, most notably Abiomed (NSDQ:ABMD), are already in this space. St. Jude Medical (NYSE:STJ) is looking to enter the percutaneous pump market with the HeartMate PHP device it acquired in the $3 billion buyout of Thoratec earlier this fall. Abiomed ...
Source: Mass Device - October 22, 2015 Category: Medical Equipment Authors: Mark Hollmer Tags: Cardiac Assist Devices Abiomed Inc. Procyrion Source Type: news
TCT 2015: Thrombectomy no benefit in Medtronic’s Export studies
Thrombus aspiration in heart attack patients showed no benefit and raised the risk of stroke, according to a pair of studies of percutaneous coronary interventions using Medtronic‘s (NYSE:MDT) Export aspiration catheter, presented today at the annual Transcatheter Cardiovascular Therapies conference in San Francisco.
Early thrombectomy’s promise Totaled?
The 10,064-patient Total study compared PCI alone and PCI with thrombectomy in ST-elevated myocardial infarctions within 12 hours of onset. The primary endpoint (a composite of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or class...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Medtronic TCT 2015 Source Type: news
TCT 2015: Medtronic touts CoreValve TAVI real-world registry data
Update: Added data from study of new patient populations
Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device.
The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. Data from all of the CoreValve studies was presented at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco.
The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study repo...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic TCT 2015 Source Type: news
Medtronic touts CoreValve TAVR real-world registry data
Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve replacement, reporting outcomes in-line with its clinical trials of the device.
The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study reported a 5.2% rate of all-cause mortality and 2.6% rate of stroke at 30 days. Those rates are consistent with the 6.9% and 5% rates, respectively, from the pivotal trial, Fridley, Minn.-based Medtronic said.
“It is reassuring to see that the profound clinical results in the U.S. CoreValve Pivotal studies were replica...
Source: Mass Device - October 12, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic Source Type: news
Silk Road launches Enroute transcarotid stent
Silk Road Medical said today it launched its Enroute Transcarotid stent system in the U.S., and that the stent was used in its 1st commercial commercial case.
The Enroute stent is indicated for use in patients at high surgical risk in conjunction with the company’s transcarotid Neuroprotection system, the Sunnyvale, Calif.-based company said. The stent is also the 1st designed to be implanted into the carotid artery through a common access point.
“The minimally invasive TCAR procedure allows me to safely and quickly treat a carotid artery blockage while minimizing the potential for nerve injury and cardiovascul...
Source: Mass Device - October 6, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blog Silk Road Medical Inc. Source Type: news
Neuravi launches EmboTrap in Europe
Neuravi said today it launched its EmboTrap minimally invasive thrombectomy device for the treatment of acute ischemic stroke in Europe.
The Embotrap device functions by capturing clots and allowing blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke, CEO Eamon Brady told MassDevice.com in an interview in June.
“One of the things Neuravi has done that’s unique to all of our competition is we have launched a huge research effort over the last 5 years in understanding the properties of clots – the cause of ischemic stroke – and we’re going to continue to ...
Source: Mass Device - October 1, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Cardiovascular Catheters Stents Neuravi Limited Source Type: news
Thoratec HeartMate 3 CE trial meets primary endpoint
Thoratec (NSDQ:THOR) said today the CE Mark trial of its HeartMate 3 left ventricular assist device has met its primary endpoint and reported a 92% rate of survival at 6 months. Data from the trial was presented at the Heart Failure Society of America’s annual meeting in Washington D.C.
The HeartMate 3 is a centrifugal-flow chronic left ventricular assist system which uses magnetically levitated technology and a reduced size for easier placement, the Pleasanton, Calif.-company said.
“The CE Mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material i...
Source: Mass Device - September 28, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Thoratec Corp. Source Type: news
