The FDA’s Circulatory Devices panel recommended expanded approval for Edwards Lifesciences‘ (NYSE:EW) Sapien heart valve to include a lower-risk group of patients, voting 11-0 in favor of approval with 1 panelist not voting.
Replacement Heart Valves
MassDevice.com +3 | The top 3 med-tech stories for June 11, 2012.
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FDA: Possible selection bias issues ‘confound’ Edwards’ Sapien study
UPDATED 6/11/2012 2:30 p.m. with comment from Edwards
Edwards Lifesciences wins FDA okay for new GLX heart valve trial
Edwards Lifesciences (NYSE:EW) won FDA approval to begin human clinical trials of a new heart valve tissue treatment process that may make the implants more durable.
Boston Scientific lands FDA win for new stent lengths | Regulatory Roundup
MassDevice.com +3 | The top 3 med-tech stories for May 29, 2012.
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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.
EuroPCR: Renal denervation devices take center stage
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.
EuroPCR: Warnings on TAVI in replacing surgically implanted prosthetic valves
Although patients may benefit from having a failed aortic valve prosthetic reinforced via transcatheter aortic valve implantation, researchers warned against making the procedure a common practice.
MassDevice.com +3 | The top 3 med-tech stories for May 15, 2012.
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