The FDA approved labeling revisions for Edwards Lifesciences Corp.’s  Sapien Transcatheter Heart Valve (THV), expanding its availability to a group of patients who have inoperable aortic valve stenosis.  

Patients with severe aortic valve stenosis require a heart valve replacement and usually undergo open-heart surgery. However, about 30% of patients are considered inoperable or at high-risk for surgical complications and are not referred for this procedure.

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The Sapien THV is implanted without opening the chest or heart. The device is compressed into a thin, flexible delivery catheter, and is inserted into an access point in the body where it is threaded to the site of the diseased valve.

The new labeling removes references to previously specified access points (eg, transfemoral, transapical), making it available for inoperable patients who need an alternate access point. 

Data from the Transcatheter Valve Therapy Registry (TVTR) in the U.S. was based on several thousand procedures performed on patients via an alternative access point. Analyses showed no evidence that the device performs differently or has a different benefit-risk profile based on the access point.

The TVTR is managed by the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS).

For more information call (888) INFO-FDA or read more about the Edwards SAPIEN THV.