Sapien Heart Valve Gets FDA Panel Nod For High-Risk Surgical Patients
This article was originally published in The Gray Sheet
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.
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In an interview with Medtech Insight, the lead investigator of SURTAVI, an ongoing trial of Medtronic's CoreValve in intermediate risk patents, says transcatheter aortic valve is continuously improving and will probably soon be indicated for even low-risk patients, but that surgical valve replacement will have an important role to play for the foreseeable future.
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.
Brief summaries of recent medtech market and industry developments. This month we cover continuing pressures on the DES and ICD markets, update Edwards’ efforts to roll out its Sapien device for TAVR, and report on QLT’s decision to sell its punctal plug technology.