FDA Approves Abbott Vascular's MitraClip

October 25, 2013—Abbott Vascular (Santa Clara, CA) announced that its catheter-based MitraClip therapy has received US Food and Drug Administration approval and will launch immediately in the United States. The MitraClip device has been approved for patients with significant symptomatic degenerative mitral regurgitation who are at prohibitive risk for mitral valve surgery. Prohibitive risk is determined by the clinical judgment of a heart team due to the presence of one or more documented surgical risk factors.

The MitraClip is delivered transfemorally and once implanted, allows the heart to pump blood more efficiently, thereby relieving symptoms and improving patient quality of life. Patients undergoing MitraClip treatment typically experience short recovery times and short hospital stays of 2 to 3 days, stated the company.

In Abbott Vascular’s announcement, Ted Feldman, MD, commented, “MitraClip is a breakthrough in the treatment of severe mitral regurgitation, a condition that is progressive and causes extreme fatigue and shortness of breath, eventually making even simple tasks virtually impossible, and increasing the risk of stroke, heart failure, and death. Clinical data and real-world international experience, dating back to 2003, have consistently shown that the MitraClip is a safe and effective therapy for patients unable to undergo mitral valve surgery, providing meaningful improvements in quality of life that are sustained over time. It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment. Approval of this first-in-class, non-surgical therapy therapy for MR opens the door to treatment for many high-risk patients who have never had an option in the past.” Dr. Feldman is Director, Cardiac Catheterization Laboratory and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem in Evanston, Illinois.

Michael Mack, MD, who is Director of Cardiovascular Research and Cardiovascular Medicine and Director of Cardiovascular Surgery at Baylor Health Care System in Dallas, Texas, added, “As cardiac surgeons, we see patients with severe mitral regurgitation who we can technically operate on but who are just too frail or sick to survive mitral valve surgery with a reasonable risk and quality of life. With the MitraClip system, heart teams now have a catheter-based, less-invasive treatment option that can help patients who cannot withstand surgery regain their quality of life.”

According to Abbott Vascular, multiple trials, published reports, and registries of patients treated with the MitraClip device consistently demonstrate a positive safety profile, reduction in mitral regurgitation, improvement in symptoms, and reduction in hospitalizations for heart failure, even in some of the most ill and debilitated patients. The MitraClip device received European CE Mark approval in 2008 and has been used to treat more than 11,000 patients in more than 30 countries.

Abbott Vascular advised that it continues to conduct clinical trials of the MitraClip therapy through two landmark, prospective, randomized trials—COAPT in the United States and RESHAPE-HF in Europe—that will evaluate the impact of MitraClip treatment on the progression of heart failure. Both studies are currently enrolling patients. The studies also will generate important clinical and economic data that may support development of treatment guidelines, expanded indications, and reimbursement, stated Abbott Vascular.