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MitraClip, a catheter-delivered device, has been approved by the US Food and Drug Administration (FDA) for treatment of patients with significant symptomatic degenerative mitral regurgitation who are at prohibitive risk for surgery, device maker Abbott Vascular announced October 25, 2013.
The approval comes in the wake of a narrow FDA advisory committee decision made this March that the benefits of the device outweigh its risks in this patient group. Although the panel was nearly unanimous in support of MitraClip’s safety, a vote on efficacy went against the device by a 5 to 4 margin.
The MitraClip system (Abbott Vascular, Santa Clara, CA) involves a clip that is inserted into the mitral valve via percutaneous femoral venous transseptal access. The device is then aligned above the valve in order to secure the mitral leaflets, creating a bridge that supports durability of repair and may limit dilatation of the annulus.
Heart Teams Make the Call
According to an Abbott press release, “prohibitive risk” is determined by the clinical judgment of a heart team based on the presence of at least 1 documented surgical risk factor.
In the same statement, Michael J. Mack, MD, of Baylor Health Care System (Dallas, TX), said, “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.”
Ted E. Feldman, MD, of Evanston Hospital (Evanston, IL), principal investigator for the pivotal randomized Endovascular Valve Edge-to-Edge Repair Study (EVEREST II), called MitraClip “a breakthrough in the treatment of severe mitral regurgitation” in the release.
“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,” Dr. Feldman continued. “It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment.”
According to Abbott, 2 prospective randomized trials evaluating the impact of MitraClip treatment on the progression of heart failure (COAPT in the United States and RESHAPE-HF in Europe) are currently enrolling patients. An FDA executive summary, issued shortly before the advisory panel meeting, noted that these trials are well designed and should “help to answer the many important questions posed by the very limited data analyses presented in this [premarket approval] and the mitral regurgitation literature.”