October 25th, 2013
FDA Approves Abbot’s MitraClip for Patients at Prohibitive Surgical Risk
Larry Husten, PHD
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
Larry Husten, PHD
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
Larry Husten, PHD
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 […]
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