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TCT 2017: Boston Scientific touts lowered hemorrhagic stroke rate, cost for patients in Watchman studies
Boston Scientific (NYSE:BSX) today released combined 5-year outcomes data from both the Prevail and Protect-AF study of its Watchman left atrial appendage closure device, touting it as a safe and effective an alternative to long-term warfarin therapy for patients with non-valvular atrial fibrillation.
Five-year data from the Prevail study was published online today in the Journal of the American College of Cardiology.
In both trials, the Marlborough, Mass.-based company compared the Watchman device to warfarin treatment for stroke prevention in patients with non-valvular AF with follow-ups out to five years. A combined an...
Source: Mass Device - November 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
Boston Scientific touts 1-year stroke reduction results in Watchman non-valvular AF trial
Boston Scientific (NYSE:BSX) today released 1-year results from the Ewolution registry study of its Watchman left atrial appendage closure device, touting a high implant success rate and stroke reduction in patients with non-valvular atrial fibrillation patients.
Data was presented today at the Heart Rhythm Society’s 39th Annual Scientific Sessions in Chicago.
“We are pleased to see that these ‘real-world’ results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials,” rhythm man...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose.
“Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “Iâ€...
Source: Mass Device - November 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Boston Scientific Source Type: news
MassDevice.com +3 | The top 3 medtech stories for December 15, 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. Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman t...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news
Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts.
Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could later cause a stroke.
The study, published online in the Journal of the American College of Cardiology, showed that the Watchman device was cost-effective at 7 years at a cost of $42,994 per quality-adjust...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Wall Street Beat Cardiovascular Cardiac Implants Clinical Trials Boston Scientific Reimbursement Source Type: news
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
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 wins CE Mark for next-gen Watchman FLX
Boston Scientific (NYSE:BSX) said today it won CE Mark approval in the European Union for its Watchman FLX left atrial appendage closure device, and announced the device has been successfully implanted in its 1st set of patients.
The 1st Watchamn FLX devices were implanted last week by Dr. Horst Sievert of Frankfurt, Germany’s Sankt Katharinen Hospital, Dr. Vivek Reddy of Mt. Sinai Hospital in Prague’s Na Homolce Hospital and by Dr. Saibal Kar of Cedars-Sinai Heart Institute at Izola, Slovenia’s MC Medicor, Marlborough, Mass.-based Boston Scientific said.
“The Watchman Device is the most studied l...
Source: Mass Device - November 19, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Regulatory/Compliance Boston Scientific Source Type: news
MassDevice.com +3 | The top 3 medtech stories for November 12, 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. SurgiQuest files for $75m IPO
SurgiQuest this week registered for an initial public offering estimated at $75 million.
Milford, Conn.-based SurgiQuest makes the AirSeal device for use in minimally invasive abdominal surgeries. AirSeal is designed to insufflate the rectum and provide continuous...
Source: Mass Device - November 12, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 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
New Watchman study reports positive data
New data from a study of Boston Scientific (NYSE:BSX)’s Watchman left atrial appendage closure device reports positive results in a study comparing it to warfarin, an anticoagulant drug treatment, in patients with nonvalvular atrial fibrillation.
The 2,406-patient study, published in the Journal of the American College of Cardiology, reported a lower rate of hemorrhagic strokes, unexplained and cardiovascular death and non-procedural bleeding when compared to warfarin.
“I think the fact that we now actually have some good scientific data in the field is terribly important, it has been lacking. But I think we...
Source: Mass Device - June 16, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Stroke Source Type: news
HRS 2015: Boston Scientific touts cost-saving data for Watchman
Boston Scientific presents data at the Heart Rhythm Society's annual meeting showing that its Watchman anti-stroke device lowers costs compared with the blood thinner warfarin and aspirin.
Boston Scientific, HRS 2015News Well, Clinical Trials, Cardiac Implants, Strokeread more
Source: Mass Device - May 14, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news
The last reprogramming
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine.
By Westby G. Fisher, MD, FACC
He had called the other day to update me up on his condition. He did not sound upset, but resolute. "They offered me peritoneal dialysis," he said, "but I decided against it and figured I'd just let nature take its course. The hospice people are so wonderful - I've got things all set here at home, but I ha...
Source: Mass Device - September 29, 2014 Category: Medical Equipment Authors: MassDevice Tags: Dr. Wes Source Type: news
