Kirkland, WA's Cardiac Dimensions touted a post-market, observational study of 17 patients of its CE-marked Carillon transcatheter mitral valve repair device. All but one of the "real world" patients were able to receive the device, which is deployed through the neck's jugular vein, enabling a beating heart procedure instead of open heart surgery. Moreover, the Carillon reduced mitral regurgitation, and additional improvement was seen after three months, according to the Journal of Invasive Cardiology. The Carillon is designed to treat functional (as opposed to degenerative) mitral regurgitation by reducing the size of the annulus. A study in the New England Journal of Medicine found that mitral valve replacement is superior in patients with that form of the disease, but company vice president Omari Bouknight said in an interview that the paper studied surgical devices only, not minimally invasive transcatheter ones. Plus, surgical mitral valve replacements have not yet overcome significant safety and engineering challenges, leaving repair as the only commercially available transcatheter option for the mitral valve. Cardiac Dimensions has received reimbursement in Germany, Turkey and Saudi Arabia. It plans to file for FDA permission to conduct U.S. clinical trials this year, Bouknight said. Meanwhile, competitor Mitralign just received a CE mark for its transcatheter repair device that's also aimed at treating the functional form of mitral regurgitation. More | Here's the study
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