|The FDA wants more data before considering approval for Abbott Laboratories' MitraClip.--Courtesy of Abbott Laboratories|
With all of the FDA's safety worries about Abbott's ($ABT) MitraClip System very much in mind, a panel of experts gave the product a mixed endorsement after a day-long hearing on March 20.
Healio, Forbes and others report that the FDA Circulatory System Devices Panel ultimately voted 5-3 that the benefits of using MitraClip to treat symptomatic mitral regurgitation for high surgical risk patients outweighed any risks. They also voted 8-0 that the device is safe, but a 5-4 vote came out against the device's effectiveness.
Abbott put a positive spin on the vote outcome.
"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," Charles Simonton, Abbott Vascular's divisional vice president, Medical Affairs, and chief medical officer, said in a prepared statement.
Mitral regurgitation can lead to heart failure. It is a condition where the mitral valve doesn't close all the way, contributing to inefficient blood flow. MitraClip reaches the heart by way of the femoral vein in the leg and helps reduce mitral regurgitation by clipping together parts of the mitral valve "leaflets" so blood pumps more efficiently, the company explains.
And now MitraClip's U.S. approval pathway gets more complicated. As Healio notes, the device is used in more than 40 countries. It's had a CE marking since 2008. Abbott tried to make its case before the FDA advisory panel that data from the pivotal EVEREST II trial showed MitraClip reduced mortality rates and improved patients' quality of life. But FDA staff in advance of the hearing came out for delaying approval, arguing that Abbott hadn't proved that MitraClip was safer than traditional mitral valve surgery, and had no greater risk-benefit result either. Instead, the FDA wanted to delay approval until Abbott collects more data from its ongoing U.S. and international trials.
Panel recommendations aren't binding, but the FDA takes them into account when making a final decision to approve or reject a device.
Editor's note: The story has been updated with comments from Abbott's statement.