This 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 XT Transcatheter Heart Valve and accessories
PMA Applicant: Edwards Lifesciences LLC.
Address: One Edwards Way, Irvine, CA 92614
Approval Date: June 16, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009a.pdf
What is it? The Edwards SAPIEN XT Transcatheter Heart Valve (often referred to as the SAPIEN XT) consists of a catheter-based artificial aortic heart valve and accessories used to implant the valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support.
How does it work? The SAPIEN XT is compressed and placed on the end of a tube-like device called a balloon catheter. It is then inserted through the femoral artery in the leg. If the femoral arteries are not suitable, the valve can also be inserted through other arteries, the tip of the heart, or through the aorta. The catheter is pushed through the blood vessels until it reaches the diseased aortic valve. The valve is then expanded by the balloon and it anchors to the diseased valve. The SAPIEN XT functions the same as a normal valve, helping the blood flow properly by opening and closing like a door to force the blood to flow in the correct direction.
When is it used? The SAPIEN XT is used in patients whose own aortic heart valve is diseased due to calcium build up, which causes the valve to narrow (aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak. This 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 if the diseased valve is not replaced.
The SAPIEN XT should only be used in patients who cannot undergo, or are at high risk for open heart surgery as determined by their heart team (a cardiologist and surgeon).
What will it accomplish? The SAPIEN XT can help correct the blood flow problem associated with aortic stenosis in patients who need open-heart surgery to replace the diseased valve, but the surgical procedure is highly risky, or too risky. In the clinical studies, the SAPIEN XT was shown to be reasonably safe and effective for those patients without the need for open-heart surgery. However, implanting the SAPIEN XT also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, and complications with the arteries used to insert the valve. For some patients with coexisting conditions or diseases, the risks may be especially high. Patients should discuss with their doctors the benefits and risks of this device.
When should it not be used? The SAPIEN XT should not be used in patients who:
- have an infection in the heart or elsewhere.
- have an artificial (mechanical) aortic valve.
- cannot tolerate blood thinning medicines.
- have sensitivity to the fluid used during the procedure to see internal structures (contrast media).
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.