November 3rd, 2011

Sapien Transcatheter Aortic Heart Valve Gains FDA Approval

After much anticipation and drama, the FDA has approved the Sapien transcatheter heart valve (THV). The news was announced late Wednesday afternoon by the FDA and by Edwards Lifesciences, the manufacturer of the device.

Details about the approval are scarce. The FDA said the Sapien THV has been “approved for patients who are not eligible for open-heart surgery for replacement of their aortic valve and have a calcified aortic annulus (calcium build-up in the fibrous ring of the aortic heart valve).” In addition, the product label “advises that a heart surgeon should be involved in determining if the Sapien THV is an appropriate treatment for the patient.”

In its announcement, the FDA noted that although patients in the pivotal PARTNER B trial who received Sapien had two and a half times the number of strokes and eight times as many vascular and bleeding complications as medically treated controls, after 1 year 69% of patients in the Sapien group were alive, compared with only 50% of controls.

The FDA also said that Edwards “will continue to evaluate the outcomes with the Sapien THV through a national Transcatheter Valve Therapy (TVT) registry,” which is under development by the Society of Thoracic Surgeons and the American College of Cardiology, in conjunction with the FDA and CMS. In its statement, Edwards said it would also continue to follow patients enrolled in the PARTNER trial.

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