FDA has expanded the approved indication for the Sapien transcatheter heart valve developed by Edwards Lifesciences Corp., according to a news release.
The Sapien THV is now approvaed to include patients with aortic valve stenosis who are eligible for surgery, but who are at high risk for serious surgical complications or death.
The FDA first approved the Sapien in 2011 for patients with inoperable aortic valve stenosis. The Sapien is implanted without opening the chest or heart. The device is compressed into a delivery catheter. The delivery catheter and the THV are inserted into the femoral artery through a small incision in the leg and threaded to the site of the diseased valve. The THV is then released from the delivery catheter and expanded with a balloon and is immediately functional.
The Sapien is approved for those who have a calcium build-up in the fibrous ring of the aortic heart valve and are either not eligible for open-heart surgery or who are considered to be a very high-risk surgery patient by a cardiologist or thoracic surgeon.
Edwards Lifesciences Corp. is headquartered in Irvine, Calif.
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