Boston Scientific lands expanded FDA indication for biliary stone removal with CRE dilator
Structural Heart
MassDevice.com +3 | The top 3 med-tech stories for May 29, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech 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.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Recalls: Edwards pulls Perimount heart valves over packaging concerns
Edwards Lifesciences (NYSE:EW) issued a recall of certain lots of Perimount replacement heart valves over concerns that they may have been contaminated with "extremely small" metallic particles during packaging.
FDA panel wants a closer look at St. Jude’s Amplatzer data
An FDA panel recommended that the agency’s Center for Devices & Radiological Health re-analyze existing data for St. Jude Medical‘s (NYSE:STJ) Amplatzer heart implant during a hearing yesterday to review safety data for the Amplatzer and for W.L. Gore & Associates‘ Helex implant.
Diabetes: Medtronic’s Resolute stent performs well in non-diabetics, too | Wall Street Beat
FDA panel to review St. Jude, W.L. Gore heart implants today
An FDA panel is scheduled for a hearing today to review post-market surveillance data for a pair of cardiac implants made by St. Jude Medical (NYSE:STJ) and W.L. Gore & Associates.
Cook launches peripheral drug-eluting stent in Australia | Regulatory Roundup
EuroPCR: Renal denervation devices take center stage
Sorin wins Japanese OK for annuloplasty ring | Regulatory Roundup
EuroPCR: “Excellent” safety, effectiveness for BSX’s Promus Element in small vessels
Boston Scientific (NYSE:BSX) unveiled new study results at the EuroPCR meeting in Paris today, touting the "excellent" safety and effectiveness of its Promus Element drug-eluting stents in small coronary vessels.
EuroPCR: Sapien win, promising post-approval results weigh in Edwards’ favor
Leerink Swann analysts saw promise in a pair of "tidbits" about Edwards Lifesciences’ (NYSE:EW) Sapien XT transcatheter aortic valve implantation system presented at the EuroPCR conference in Paris this week.