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Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System – P140031/S125

Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System – P140031/S125

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 and SAPIEN 3 Ultra Transcatheter Heart Valve System
PMA Applicant:  Edwards Lifesciences LLC
Address:  One Edwards Way, Irvine, CA 92614
Approval Date:   May 13, 2021
Approval Letter:  Approval Order

What is it? 

The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve (THV) System is a catheter-based artificial heart valve system designed to replace a diseased heart valve without open-heart surgery. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. The SAPIEN 3 Ultra valve is a modified version of the SAPIEN 3 valve.

This current approval expands the use of this device to include using it to replace a failing mitral valve in patients who are too high risk for open-heart surgery when the valve has already been repaired with an artificial (prosthetic) ring.

The Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System was previously approved for the treatment of severe aortic stenosis (narrowing of the aortic valve) of the patient’s own heart valve. It was also approved for the replacement of a failing (narrowed, leaky, or both) previously implanted surgical biological aortic or mitral valve, or transcatheter aortic valve in patients who are too high risk for open-heart surgery.

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 moves the catheter with the mounted valve through the femoral vein in the leg. The catheter is pushed through the blood vessels until it reaches the failing mitral valve. The new artificial valve is then expanded by a balloon and anchors to the previously implanted prosthetic ring around the mitral valve. Once the new valve is in place, it functions the same as the old valve, opening and closing like a door to guide blood flow in the correct direction.

When is it used? 

The SAPIEN 3 and SAPIEN 3 Ultra THV are used when the mitral valve fails and the patient already had a prosthetic ring implanted around the mitral valve to help keep its shape. When a valve fails, the heart works harder to pump enough blood and eventually weakens. This can lead to life-threatening heart problems such as heart failure.

The SAPIEN 3 and SAPIEN 3 Ultra 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 a failing mitral valve previously repaired with a prosthetic ring. This is determined by their heart team, including a cardiologist and surgeon.

What will it accomplish? 

Results from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and a physician-led clinical study showed that on average, patients had fewer limitations on physical activity and an improved quality of life after their failing mitral valve with prosthetic ring was replaced with a SAPIEN 3 THV.

Any procedure to replace the mitral valve carries risks for serious complications. In the available clinical data about the device, the major risks observed included death (about 29 out of 100 patients at one year for all causes and about 10 out of 100 patients at one year for heart-related causes), new need for dialysis (about 7 out of 100 patients at one year), and readmission to the hospital due to heart failure (about 23 out of 100 patients at one year).

For some patients with other conditions or diseases, the risk of complications may be especially high. Patients should discuss with their doctors the benefits and risks of this device with their heart team.

When should it not be used? 

The SAPIEN 3 and SAPIEN 3 Ultra THV System should not be used in:

  • Patients who cannot tolerate blood thinning medicines.
  • Patients who have an infection in the heart or elsewhere.
  • Patients who have a prosthetic mitral valve ring that is damaged and can no longer support the valve.

Additional information (including warnings, precautions, and adverse events): 

 
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