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 […]
Cardiac Implants
J&J’s Biosense Webster buys Coherex Medical and its WaveCrest anti-stroke device
Johnson & Johnson (NYSE:JNJ) subsidiary Biosense Webster said today that it acquired Coherex Medical for an undisclosed amount. Salt Lake City-based Coherex makes the Wavecrest anti-stroke device, which is designed to occlude the heart’s left atrial appendage to prevent blood clots from forming that could cause stroke. “The addition of the Coherex WaveCrest system complements […]
Cordis touts 4-year data on Incraft AAA stent graft
Cordis Corp. said today that 4-year data from a trial of its Incraft abdominal aortic aneurysm stent graft system showed it “performed well” in patients suffering from AAAs 4 years after treatment. Data from the study was presented at the VEITHsymposium in New York City this week. The multi-center, open-label prospective Innovation trial reported a 97% […]
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. […]
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 […]
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 […]
Medtronic’s Micra pacer trial meets endpoints
Medtronic‘s (NYSE:MDT) entry into the micro-sized leadless pacemaker market has met its primary safety and effectiveness endpoints with “wide margins,” the company said today. The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the […]
Boston Scientific, Edwards facing off in new TAVR battle
Updated: Included information from the Edwards settlement in May. A new patent spat is being fought in Germany by Boston Scientific (NYSE:BSX), which alleges that Edwards Lifesciences (NYSE:EW) is infringing on a patent associated with its Lotus transcatheter heart valve. Late last month, Boston Scientific filed the patent infringement in Dusseldorf alleging that the Edwards Sapien 3 transcatheter aortic valve replacement […]
TAVI: Direct Flow’s LeMaitre touts real-world data for next-gen heart valve
Direct Flow Medical said last week that 1-year data from a post-market study of its transcatheter aortic valve implantation system showed a 95% rate of mild or no paravalvular regurgitation. The low rate of paravalvular leaks is of primary importance to the TAVI market, Direct Flow CEO Dan LeMaitre told MassDevice.com last week, as the procedures become more common […]
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. […]
EBR Systems wins CE Mark for wireless pacer
EBR Systems said Monday it won CE Mark approval in the European Union for its WiSE wireless endocardial cardiac resynchronization therapy device. The EBR device uses a subcutaneous generator to wirelessly deliver ultrasound energy to a “pellet” implanted on the inside of the heart, in the right ventricle, which it uses to synchronize the left […]