First PARTNER II Results Show Progress With Edwards’ TAVR Technology
This article was originally published in The Gray Sheet
Next-generation Sapien XT transcatheter aortic valve replacement met its non-inferiority endpoint, and showed some procedural advantages over the FDA-approved Sapien device in the latest data from Edwards Lifescience’s TAVR program, presented at the 2013 American College of Cardiology Scientific Sessions in San Francisco.
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The firm now expects to gain approval for the extreme-risk indication of its transcatheter aortic heart valve months earlier than earlier predicted following well-received pivotal trial data reported last week at the Transcatheter Cardiovascular Therapeutics meeting.
Societies Gain FDA Go-Ahead, Medicare Coverage To Study New Access Methods For Edward’s Sapien Valve
It’s the first time Society of Thoracic Surgeons and American College of Cardiology have ever filed for an investigational device exemption. The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.