FDA votes that the benefits of MitraClip outweigh the risks


Abbott Vascular has announced that the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted five to three that the benefits of its MitraClip system for the management of mitral regurgitation outweigh its risks. However, the panel also voted five to four that there was not a reasonable assurance of the device’s efficacy.

Abbott Vascular is seeking FDA approval for the MitraClip device, which received CE mark approval in 2008, to be marketed in the USA as a treatment for patients with significant symptomatic mitral regurgitation who cannot undergo open mitral valve surgery due to a high risk of complications.

As well as voting five to three that the benefits of the device outweighed its risks, the FDA panel also voted that there was a reasonable assurance its safety (eight saying yes vs. 0 saying no). However, the panel voted five to four against there being a reasonable assurance of MitraClip’s efficacy. According to an Abbott Vascular press release, the FDA will take into account the panel’s advice in making its decision on whether to approve the MitraClip in the USA. The company expects a decision later this year.

“We appreciate the FDA’s dedication of time and resources to convene this advisory panel for MitraClip and for its review of this new and novel technology for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation,”  said Charles A Simonton, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “We are pleased with the outcome of today’s panel, and we look forward to continuing discussions with the agency regarding the panel’s comments.”

The committee’s recommendation followed a review of data from a large and growing body of clinical evidence (EVEREST II, EVEREST II High Risk and REALISM) in which the MitraClip therapy demonstrated positive and consistent results for high surgical risk patients suffering from the debilitating symptoms of significant mitral regurgitation, including a safe procedure, reduction in mitral regurgitation, reverse left ventricular remodelling, improvement in heart failure symptoms, improvements in quality of life, and reduced rates of re-hospitalisation.