Edwards Wins Approval For Sapien Just In Time For TCT

Approval of the first U.S. transcatheter aortic heart valve came slightly later than Edwards Lifesciences anticipated, but Sapien will reach the market just in time for a highly anticipated debut at the Transcatheter Cardiovascular Therapeutics annual meeting in San Francisco this week.

Edwards Lifesciences gained FDA approval Nov. 2 for its Sapien transcatheter valve for severe aortic stenosis patients deemed too sick...

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A federal court in Illinois ruled against SurModics and BC Holdings' request for FDA documents to support a proposed merger. The FTC has challenged the merger, claiming it threatens competition in hydrophilic device coatings. The ruling may indicate the FTC is likely to succeed.