Using Registry Data, FDA Expands Indication For Edwards’ Sapien Transcatheter Heart Valves

Relying on an important new source of information. the FDA said today that it had expanded the label for the Sapien Transcatheter Heart Valve (Edwards Lifesciences). Previously the Sapien was approved for insertion via the transfemoral or transapical access points in patients not eligible for traditional aortic valve surgery. The new labeling no longer mentions access points and therefore allows for alternative access points such as the subclavian.

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). The TVTR, 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. The TVTR data, according to the FDA, showed no evidence that the access point changed the benefit-risk profile or the device.

Click here to read the full story on Forbes.

 

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