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FDA advisory panel recommends approving Edwards transcatheter heart valve for high risk patients.

Edwards Lifesciences Corporation, Gaithersburg, MD, announced an FDA Advisory Panel unanimously voted in favor of recommending approval of the Edward's SAPIEN transcatheter heart valve via transfemoral and transapical delivery for the treatment of high-risk patients with severe, symptomatic aortic stenosis.

Edwards submitted a Premarket Application (PMA) in April 2011 based on data from the high-risk cohort(A) of The PARTNER Trial. Cohort A compared the outcomes of patients at high risk for traditional open-heart surgery evenly randomized to receive either surgical aortic valve replacement or the Edwards Sapien valve via transfemoral or transapical delivery. In November 2011, the FDA approved Sapien via transfemoral delivery for the treatment of inoperable patients with severe, symptomatic aortic stenosis.

In early July, Edwards announced it had received a conditional investigational Device Exemption (DE) from the FDA to initiate the TRANSFORM Trial, a prospective, multi-year study that will evaluate the company's Intuity valve system. The trial is the first US clinical trial of a rapid deployment system for surgical aortic valve replacement (AVR) procedures. The Edwards Intuity valve system, which consists of a bovine pericardial heart valve and novel balloon-expandable frame, is designed to facilitate small incision surgery and rapid valve deployment with the goal of enabling faster procedures.

The trial will study the safety and effectiveness of the Intuity valve system in a single arm study.

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Title Annotation:Business Briefs
Publication:Transplant News
Date:Jul 1, 2012
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