U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. Recently-Approved Devices
  6. Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S085
  1. Recently-Approved Devices

Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System - P140031/S085

Image of the device.

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 System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System
PMA Applicant: Edwards Lifesciences LLC
Address: One Edwards Way, Irvine, CA 92614
Approval Date: August 16, 2019
Approval Letter: Approval Order

What is it? The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System each 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.

The Edwards SAPIEN 3 THV System and Edwards SAPIEN 3 Ultra THV System were previously approved for the treatment of severe aortic stenosis (a narrowing of the aortic valve that restricts blood flow to aorta, the body's main artery) in patients at intermediate and greater risk for surgical therapy. This approval expands the indications for use to patients at low risk for surgical therapy.

How does it work? The doctor compresses the SAPIEN 3 or SAPIEN 3 Ultra THV and places it on the end of a tube-like device called a balloon catheter. The doctor then inserts the SAPIEN 3 or SAPIEN 3 Ultra THV through an artery in the leg, the artery in the neck, or through a small cut between the ribs. The catheter is pushed through the blood vessels until it reaches the diseased aortic valve. The valve is then expanded by a balloon and it anchors to the diseased valve. Once the new valve is in place, it functions the same as the old valve, opening and closing like a door to force the blood to flow in the correct direction.

When is it used? The SAPIEN 3 are SAPIEN 3 Ultra THVs are 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, it 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.

The SAPIEN 3 and SAPIEN 3 Ultra THVs should only be used in patients who are considered to be appropriate for the transcatheter heart valve replacement therapy by their heart team (including a surgeon).

What will it accomplish? The SAPIEN 3 and SAPIEN 3 Ultra THVs can improve blood flow in patients with aortic stenosis. In the clinical study of the SAPIEN 3 THV, the device was shown to be reasonably safe and effective for treating patients with severe aortic stenosis without the need for open-heart surgery. The risk of death, disabling stroke, or rehospitalization (valve-related, procedure-related, or heart failure-related) at 1 year was about 9 out of 100 patients (8.5%) in those receiving a SAPIEN 3 THV, as compared to about 16 out of 100 (15.1%) patients in those receiving open-heart surgery.

Any procedure to replace the aortic valve carries the risk for serious complications. The serious complications associated with implanting a SAPIEN 3 or SAPIEN 3 THV include 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 these two devices.

When should it not be used? The SAPIEN 3 and SAPIEN 3 Ultra THVs 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 at:

Other Resources: