FDA staff reviewers had advised that the agency reject Abbott's application for premarket approval for its minimally invasive MitraClip device, but a panel has gone against the recomemndation, albeit by a slim majority Reuters is reporting.
The device is intended to be an alternative for patients who suffer mitral regurgiation but are not eligible for a more invasive, open heart surgery because it is too risky for them.
Mitral regurgitation occurs mitral valve doesn’t close tightly enough such that blood flows backward into the heart and not out to the rest of the body.
Abbott announced Wenesday that the FDA panel had voted to approve the device by a 5-3 vote.
"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 in a news release. "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."
In terms of the device's safety the panel was unanimous that the MitraClip posed no real danger, but they were more divided on the issue of how effective it is. In fact five panelists said there was no reasonable assurance of efficacy compared with four who said the device was reasonable effective.
Generally, the FDA heeds the recommendation of the advsiory panels and a final decision on whether the agency will approve the device is expected later this year.
-- By Arundhati Parmar, Seniore Editor, MD+DI