Edwards Receives FDA Approval For SAPIEN 3 Transcatheter Heart Valve

Industry News

Edwards Lifesciences, a cardiac device company based in Irvine, CA has received approval from the U.S.FDA for its SAPIEN 3 Transcatheter Heart Valve (THV) device for the treatment of high-risk patients suffering from severe aortic valve stenosis.  The SAPIEN 3 THV has a major design improvement that can minimize leakage around the valve compared to its predecessor that was approved by the FDA in 2011.  Aortic valve stenosis is the narrowing of the heart’s aortic valve that can lead to incomplete opening of the valve and obstruction of blood flow from the heart into the aorta and onward to the rest of the body.  Ultimately, this condition may result in weakening of the heart and impeding its function.  SAPIEN 3 THV is indicated for patients with aortic valve stenosis who are inoperable or at high risk for death or complications associated with open-heart surgery.  The approval is based on positive result from the PARTNER II trial involving 583 high-risk patients.


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