Edwards Wins Approval For Sapien Just In Time For TCT
This article was originally published in The Gray Sheet
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Edwards estimates that the approximately 20%-30% of patients who would otherwise qualify but can’t receive a Sapien valve because their femoral artery is too small would likely make good candidates for the transapical, through the ribcage, route.
Recent PMA approvals include Edwards Lifesciences’ Sapien transcatheter aortic heart valve expanded indication, Bolton Medical’s Relay thoracic stent graft and Paradigm Spine’s Coflex interlaminar stabilization device.
Edwards Lifesciences’ first-to-market transcatheter valve is safe and effective, and its benefits outweigh its risks in an expanded patient population, an FDA advisory panel says.