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
PMA Applicant: Edwards Lifesciences LLC
Address: One Edwards Way, Irvine, CA 92614
Approval Date: October 9, 2015
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf13/P130009S034.pdf
What is it? The Edwards SAPIEN XT Transcatheter Heart Valve (SAPIEN XT THV) consists of a transcatheter aortic valve and accessories used to implant the valve. It is designed to replace a failed tissue aortic valve without requiring open-heart surgery. The SAPIEN XT THV is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. It comes in three sizes: 23 mm, 26 mm, and 29 mm.
How does it work? The SAPIEN XT THV is compressed and placed on the end of a long, hollow tube (balloon catheter). The catheter is inserted through either the femoral artery in the leg or a small cut between the ribs and advanced through the blood vessels until it reaches the failed valve. The SAPIEN XT THV is then expanded with the balloon until it anchors to the failed valve (valve in valve). Once the new valve is in place, it opens and closes properly, allowing the blood to flow in the correct direction.
When is it used? The SAPIEN XT THV is used in patients who previously received a tissue aortic valve that has become narrowed, leaky, or both, so blood is not able to flow efficiently. As the heart works harder to pump enough blood, it eventually weakens, which can lead to life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythm (arrhythmia), or cardiac arrest.
The SAPIEN XT THV should only be used in patients who are at high or greater risk of death or serious complications from traditional open-heart surgery to replace the failed surgical valve, as determined by their heart team (a cardiologist and surgeon).
What will it accomplish? Implantation of the SAPIEN XT THV can improve blood flow in patients with failed tissue aortic valves who need to have their valves replaced but for whom open heart surgery is highly or extremely risky.
Any procedure to replace the aortic valve carries the risk for serious complications. In the clinical trial of the device, the major risks observed included death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve, and the need for a permanent pacemaker. For some patients with other conditions or diseases, that risk may be especially high. Patients should discuss with their doctors about the benefits and risks of this device.
When should it not be used? The SAPIEN XT THV should not be used in patients who:
- have an infection in the heart or elsewhere
- cannot tolerate blood thinning medicines
- have a mechanical (non-tissue) artificial aortic valve
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.