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 Pericardial Mitral Bioprosthesis, Model 11000M
PMA Applicant: Edwards Lifesciences, LLC.
Address: One Edwards Way, Irvine, CA 92614
Approval Date: August 9, 2018
Approval Letter: Approval Order
What is it? The Edwards Pericardial Mitral Bioprosthesis, Model 11000M is intended for use as an artificial heart valve. The valve is made of cow tissue and a cobalt-chromium metal frame. The device is surgically implanted through an open heart procedure. The original PMA (P150048) was approved on June 29, 2017 and is indicated for the replacement of native or prosthetic aortic heart valves. The current supplement was submitted to allow the device to be used to replace the mitral valve in addition to the aortic valve.
How does it work? The Edwards Pericardial Mitral Bioprosthesis is permanently implanted by a surgeon who uses sutures to stitch the valve into the heart. The new valve opens and closes properly, guiding the blood to flow in the correct direction.
When is it used? The Edwards Pericardial Mitral Bioprosthesis is used in patients who require replacement of their native or previously implanted artificial mitral heart valve that has become leaky, causing blood to flow in the wrong direction (mitral insufficiency). If left untreated, mitral valve disease can worsen and can cause heart failure and become lethal.
What will it accomplish? The Edwards Pericardial Mitral Bioprosthesis has been shown to correct leaking valves by replacing the diseased valve. Clinical studies have demonstrated a reasonable assurance of safety and effectiveness of the Edwards Pericardial Mitral Bioprosthesis for patients that can undergo heart surgery. Subjects that received the Edwards Pericardial Mitral Bioprosthesis valve showed improvements in how well their heart functioned (based on improvements in NYHA classification, effective orifice area, and pressure gradients). The device was found to be safe based on several factors including thromboembolism (vessel blockage due to a clot), thrombosis (blood clots), bleeding, valve leakage, and endocarditis (infection).
When should it not be used? The Edwards Pericardial Mitral Bioprosthesis should not be used in patients who are unable to withstand heart surgery.
Additional information (including warnings, precautions, and adverse events):