Monthly Archives: March 2013

FDA Panel Decision on Mitraclip Approval: It’s Safe and “Sort of” Effective

MitraClip, manufactured by Abbott Vascular

MitraClip, manufactured by Abbott Vascular

Today’s Circulatory System Devices Panel of the Medical Devices Advisory Committee heard testimony from Abbott Vascular, surgeons, cardiologists and patients.

The indications for the MitraClip Clip Delivery System that were being discussed were “the percutaneous reduction of significant symptomatic mitral regurgitation (MR=3+) in patients who have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing co-morbidities would not preclude the expected benefit from correction of the mitral regurgitation.”

In the end, the panel voted on three questions which relate to the approvability of the device, and the envelope goes to…well here are the votes: Continue reading


Filed under Clinical Trials / Studies, FDA, Meetings & Conferences, Patient Empowerment, Patients