The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates. The committee voted 10-2 that the Sapien device…
FDA Advisory Panel Recommends Expanded Indication For Sapien Transcatheter Heart Valve
June 14, 2012 by Leave a Comment
Live Blog: FDA Advisory Panel For Edwards Sapien Transcatheter Heart Valve
June 13, 2012 by Leave a Comment
Here’s my live-blog of the FDA’s meeting of the Circulatory System Devices Panel to consider the premarket approval (PMA) application for the Edwards Sapien Transcatheter Heart Valve for use in patients with symptomatic severe aortic stenosis who have high operative risk. As reported here earlier this week, FDA reviewers have raised a number of questions about the safety and…
Consensus Document Provides Roadmap To Uptake Of TAVI In US
January 31, 2012 by 3 Comments
Following the recent approval by the FDA of transcatheter aortic valve replacement (TAVR), the ACC, AATS, SCAI, and STS, in conjunction with several other medical organizations, have released a critical consensus document to guide use of the new landmark procedure. “We have tried to collate the evidence into a coherent road map for judicious use, rational…
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