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Friday, February 28, 2014


The Wall Street Journal (9/23, Stynes, Subscription Publication, 5.91M) reports that the Sapien heart valve by Edwards Lifesciences Corp. was approved by the Food and Drug Administration to expand access to the valve for inoperable aortic valve stenosis patients.
The AP (9/24) reports the Sapien heart valve “is approved for patients who face major risks from open-heart surgery or who are too sick to have that procedure done.” The original labeling on the device “instructed surgeons to thread the valve into place through a major artery that runs from the leg up to the heart.” Under the new approved labeling, that language is removed, “allowing surgeons to choose from multiple methods of implantation.”
Forbes (9/24, 6.03M) contributor Larry Husten writes that “the most significant part of the FDA’s announcement may be not the label change itself but the source of the data supporting the claim, the Transcatheter Valve Therapy Registry (TVTR).” This registry, “which is run by the American College of Cardiology and the Society of Thoracic Surgeons, has emerged as an model of cooperation between the FDA, industry, and medical organizations.” In a press release, director of the FDA Center for Devices and Radiological Health, Jeffrey Shuren said, “Leveraging clinical research inside the framework of a device registry to expand access to therapy for more patients is a new paradigm for the FDA, researchers, registry sponsors and the medical device industry.”

POSTED BY: Steven Almany M.D.

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