Posts Tagged ‘MitraClip’

October 25th, 2013

FDA Approves Abbot’s MitraClip for Patients at Prohibitive Surgical Risk

The FDA today approved Abbott’s catheter-based MitraClip device for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. The company said it would launch the device immediately in the United States. The device is the first percutaneous nonsurgical therapy approved for the treatment of mitral valve disease. Surgery remains the option […]

March 21st, 2013

FDA Panel Gives Tepid Endorsement to Abbott’s MitraClip

The FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to Abbott Laboratories’ MitraClip device on Wednesday. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who  have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing […]

April 4th, 2011

MitraClip Compared with Surgery in EVEREST II

The final results of the highly anticipated  EVEREST (Endovascular Valve Edge-to-Repair Study) II  were presented by Ted Feldman at the ACC Scientific Sessions in New Orleans and published simultaneously in the New England Journal of Medicine. Some 279 patients with moderately severe or severe mitral regurgitation (MR) were randomized on a 2:1 basis to either […]