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 3 Transcatheter Heart Valve
PMA Applicant: Edwards Lifesciences LLC
Address: One Edwards Way, Irvine, CA 92614
Approval Date: August 18, 2016
Approval Letter: Not Yet Available
What is it? The Edwards SAPIEN 3 Transcatheter Heart Valve (SAPIEN 3) 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 3 is compressed and placed on the end of a tube-like device called a balloon catheter. It is inserted through the femoral artery in the leg. 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. 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? SAPIEN 3 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 patients die within two (2) years if the diseased valve is not replaced.
SAPIEN 3 should only be used in patients who cannot undergo, or are at intermediate or greater risk for open heart surgery as determined by their heart team (a cardiologist and surgeon).
What will it accomplish? SAPIEN 3 can help correct the blood flow problem associated with aortic stenosis in patients who need open-heart surgery to replace the diseased valve, but are considered to be at intermediate or greater risk for complications or death associated with the procedure. A clinical study has shown a reasonable assurance that the SAPIEN 3 is safe and effective for those patients without the need for open-heart surgery. The difference in the total risk of death, stroke or greater than moderate valvular leak between patients receiving SAPIEN 3 and those receiving open-heart surgery appeared to clinically favor the SAPIEN 3 patients. However, implanting the SAPIEN 3 also carries the risk of serious complications such as death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker. 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 3 should not be used in patients who:
- have an infection in the heart or elsewhere.
- cannot tolerate blood thinning medicines.
Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness and labeling will be available online. (Not Yet Available)
- FDA Press Release
- The Society of Thoracic Surgeons – Aortic Valve
