Edwards gains FDA OK for next-gen heart valve trial

08/6/2013 | MassDevice.com (Boston)

Edwards Lifesciences has received conditional investigational device exemption approval from the FDA to enroll as many as 500 inoperable and high-risk aortic stenosis patients in a clinical study of its Sapien 3 transcatheter aortic valve implantation device. The next-generation device improves on the older versions with advanced delivery systems, a lower profile and other features, a company official said.

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