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. … Click here…
FDA Approves Abbot’s MitraClip For Patients At Prohibitive Surgical Risk
October 25, 2013 by Leave a Comment
FDA Panel Gives Tepid Endorsement To Abbott’s MitraClip
March 20, 2013 by Leave a Comment
The FDA’s Circulatory System Devices advisory panel today gave a tepid endorsement to Abbott Laboratories’ MitraClip device. 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…
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