The FDA's staff says safety and effectiveness questions remain for… (Los Angeles Times )
A device designed to repair the leaky mitral value of heart patients too sick for open-heart surgery has gotten a skeptical review from Food and Drug Administration experts. The report, which concluded the makers of the MitraClip Clip Delivery System have not yet answered "major questions of safety and effectiveness" concerning the device, was posted to the FDA website on Monday.
An FDA advisory panel is set to meet on Wednesday to consider whether to recommend approval of the first-of-its-kind gadget for the U.S. market.
Noting that patients with mitral-valve insufficiency have few options if they cannot safely undergo surgery, the FDA staff recommended that the MitraClip device "continue to remain available to this vulnerable patient population as an investigational device." That would allow the device's maker, Abbott Vascular of Temecula, to complete clinical trials underway in the United States and Europe.
The MitraClip device is designed to be threaded through the arteries and into the heart, where it would pinch partly closed the mitral valve. The clip approximates a surgical technique that prevents the backwash of blood being pumped from the heart's atrium to the left ventricle. It can be delivered without the need to stop the heart or the provision of cardiopulmonary bypass under general anesthesia.
This is the second time the makers of the heart device have come to the FDA for market approval. The FDA refused to OK an earlier effort to have the device approved broadly for patients with mitral valve insufficiency. After re-analyzing data from earlier clinical trials and launching two new ones, Abbott Vascular returned to get the FDA's approval to market the device in a narrower group of patients, those too sick for surgery involving cardiopulmonary bypass and general anesthesia.