An advisory panel for the U.S. Food and Drug Administration recently voted against the approval of an experimental, catheter-based heart device developed by Medtronic. The product was designed to treat atrial fibrillation, a common disorder in which the upper two chambers of the heart beat too rapidly. Left untreated, this disorder can greatly increase the risk for stroke.
Medtronic’s device works to treat irregular heartbeat by destroying small amounts of heart tissue in order to block incorrect impulses. Ablation devices such as this one are generally approved to treat healthy atrial fibrillation patients, but studies have shown that Medtronic’s device is effective for patients with more severe cases of the disorder. However, the device still fell short of safety goals, and as such, an FDA advisory panel concluded that the device’s risks outweighed its benefits.
Due to the fact that advisory panel votes are not set in stone, Medtronic still has an opportunity to convince the FDA that their device is safe enough to bring to market. Medtronic is one of the world’s largest manufacturers of heart-rhythm devices, and the company expects that the FDA will make a decision regarding their latest experimental product sometime within the next several months.