The FDA has approved the Edwards SAPIEN Transcatheter Heart Valve only for those patients with severe aortic stenosis who have been determined by a cardiac surgeon to be ineligible due to age or other medical conditions for traditional open-heart aortic valve replacement.

This minimally invasive alternative involves delivering a collapsible artificial valve into the heart using a catheter inserted through a small incision in an artery of the leg or in the chest. The artificial valve is expanded inside the diseased valve by inflating a balloon and almost immediately goes to work.

It is estimated that 300,000 U.S. patients suffer from valve deterioration each year and approximately 50,000 people undergo the conventional open-heart surgery. TVAR is proving to be a viable way to make valve replacement feasible for a broader range of patients.