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U.S. Department of Health and Human Services

Medical Devices

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Edwards SAPIEN Transcatheter Heart Valve (THV) – P110021

Image of Edwards SAPIEN Transcatheter Heart ValveThis is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Edwards SAPIEN Transcatheter Heart Valve (Model 9000TFX, sizes 23mm and 26mm) and accessories

PMA Applicant: Edwards Lifesciences

Address: Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 9261

Approval Date: October 19, 2012

Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110021a.pdf

What is it? The SAPIEN Transcatheter Heart Valve (THV) is a heart valve that is made of cow tissue attached to a stainless steel frame with a polyester skirt. It comes in two sizes, 23mm and 26 mm.

How does it work? The device is inserted into the body by cutting a small opening in the artery carrying blood to the leg (or slightly higher up), or a small cut between the ribs. The valve is put on the end of a tube-like device called a balloon catheter, and inserted into the opening in the leg or chest. The catheter is pushed through the blood vessels or through the bottom of the heart until it reaches the damaged aortic valve. The balloon on the end of the catheter is then blown up to expand the valve so it stays in place. Once the new valve is in place, it helps the blood flow properly by opening and closing like a door at the correct time to force the blood to flow in the correct direction.

When is it used? The SAPIEN THV is used in patients, whose aortic heart valve is damaged due to calcium build up, and cannot open and close properly, so blood is not able to flow efficiently. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak, which can lead to symptoms and life threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or cardiac arrest. Once symptoms of severe aortic stenosis occur, over half of the patients die within two years. The SAPIEN THV should only be used in patients who either cannot undergo open heart surgery to have their valve replaced, or in those who are at high risk of death from traditional open-heart surgery to replace the valve, as determined by the patient’s heart team (a cardiologist and surgeon).

What will it accomplish? Implantation of the SAPIEN THV can help to restore normal blood flow in the heart in patients with severe aortic stenosis who need open-heart surgery to replace the diseased valve, but for whom such a procedure is too risky. People who received this device in the clinical trial had 2 times more strokes than those who did not get the device. They also had many more complications with the arteries leading to their legs, and with leakage around the valve. Any procedure to replace the aortic valve carries the risk for serious complications, but for some patients with coexisting conditions or diseases, that risk may be especially high.

The SAPIEN THV may be a very good alternative for some very high risk patients, when the patient’s heart team determines the risks associated with an open (invasive) surgery are substantial. Patients should have an objective dialogue with their doctors about the benefits and risks of this device.

When should it not be used? The artificial heart valve and delivery system should not be used in patients who cannot tolerate blood thinning medicines, or who have active infections near the valve or in the body.

Additional information:

The Summary of Safety and Effectiveness Data and labeling are available.

Other Resources: