Edwards SAPIEN 3 Transcatheter Heart Valve - P140031/S028
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: June 5, 2017
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140031S028a.pdf
What is it? The Edwards SAPIEN 3 Transcatheter Heart Valve (often referred to as SAPIEN 3 THV) consists of a catheter-based artificial 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 THV is compressed and placed on the end of a tube-like device called a 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 or the tip of the heart until it reaches the failed valve. The valve is then expanded by the balloon and it anchors to the failed valve. The new valve opens and closes properly guiding the blood to flow in the correct direction.
When is it used? The SAPIEN 3 THV is used in patients who previously received a tissue aortic or mitral valve that has become narrowed, leaky, or both, so blood is not able to flow efficiently through the valve. The SAPIEN 3 THV was previously approved for patients whose own native aortic valves become narrowed (aortic stenosis). As the heart works harder to pump enough blood through the valve, 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 3 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 tissue valve, as determined by their heart team (a cardiologist and surgeon).
What will it accomplish? Implantation of the SAPIEN 3 THV can improve blood flow in patients with a failed tissue aortic or mitral valve who need to have their valves replaced but for whom open heart surgery is highly or extremely risky. Clinical evidence has shown SAPIEN 3 to be reasonably safe and effective for those patients.
Any procedure to replace the aortic or mitral valve carries the risk for serious complications. In the available clinical data of the device, the major risks observed included death, stroke, acute kidney injury, cardiac arrest, 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 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 are available online:
Other Resources: Press Release