October 25th, 2013

FDA Approves Abbot’s MitraClip for Patients at Prohibitive Surgical Risk

The FDA today approved Abbott’s catheter-based MitraClip device for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. The company said it would launch the device immediately in the United States. The device is the first percutaneous nonsurgical therapy approved for the treatment of mitral valve disease.

Surgery remains the option of choice for most of the 4 million people in the U.S. with mitral regurgitation (MR), but in some patients the surgical risk is very high. “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,” said Michael Mack, director of Cardiovascular Surgery at Baylor Health Care System, in an Abbott press release. “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.”

Earlier this year, the FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to MitraClip. The panel narrowly voted 5-3 in favor of the device, saying that the benefits outweighed the risks. Although panel members expressed doubts about the device’s efficacy, in the end many panel members were persuaded by the pleas of surgeons and patients asking for another option for the most difficult cases.

According to Abbott, whether a patient is at “prohibitive risk” due to the presence of one or more documented surgical risk factors will be determined by a heart team. Most patients who receive the MitraClip only need to stay in the hospital for 2-3 days.

Abbott said that more than 11,000 patients have now been treated with the MitraClip device. “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,” said Ted Feldman, director of the cardiac catheterization laboratory at NorthShore University HealthSystem in Evanston, Il. “It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment.”

The company said that it will continue to support two prospective, randomized trials evaluating the effect of the MitraClip on heart failure progression. Those trials are COAPT in the U.S. and RESHAPE-HF in Europe. Both are still enrolling patients.


2 Responses to “FDA Approves Abbot’s MitraClip for Patients at Prohibitive Surgical Risk”

  1. David Powell , MD, FACC says:

    The clip’s potential advantages over surgery may be primarily in the functional group. Many patients with functional regurgitation are at higher surgical risk (as they by definition have ventricular dysfunction, often ischemic). Furthermore, “standard” surgical approaches often do not adequately address the ventricular remodeling which drives the regurgitation. I hope that off-label use of the clip for functional regurgitation does not hamper ongoing investigations.

    More concerning is the definition of “prohibitive risk” for the degenerative regurgitation group. The FDA is clearly making a distinction between “prohibitive” and “high risk”. This is very important, as surgical mitral repair in experienced hands can be quite low risk even in the very elderly. I am aware of some “indication creep” for younger patients with degenerative MR….a worrisome potential unintended consequence of the FDA approval.

  2. Judith Andersen, AB, MD says:

    No opinion — an important set of issues, but ones that I have no expertise regarding. I welcome the ensuing discussion. Judith Andersen