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Medical Device Used To Treat A Leaky Mitral Valve Has Been Recalled

As of May 2011, performance of MitraClip, a minimally invasive procedure to correct mitral regurgitation, has been voluntarily suspended due to a problem with its catheter delivery system.

Since 2008, about 3000 patients with severe mitral valve regurgitation (leaky mitral valve) have been treated with MitraClip rather than open surgery. In this minimally invasive procedure a small clip is delivered via catheter to the heart, where it is carefully placed over the center of the mitral valve. This non-surgical option has been an important alternative for patients who may be unable to withstand open surgery. MitraClip has been advanced and investigated at NewYork-Presbyterian/Columbia since the first EVEREST trial in 2004, and is currently available throughout the U.S. as part of the EVEREST II trial.

Mitral Rgurgitation

Mitral Regurgitation: During systole, contraction of the left ventricle causes abnormal backflow (arrow) into the left atrium.
1. Mitral Valve 2. Left Ventricle 3. Left Atrium 4. Aorta

This year, three patients at other institutions experienced complications after the catheter delivery system malfunctioned and subsequent procedures were needed to correct the problem. No patients at NewYork-Presbyterian/Columbia experienced that complication. According to Susheel K. Kodali, MD, Assistant Professor of Clinical Medicine, Center for Interventional Vascular Therapy, Columbia University College of Physicians and Surgeons, “The problem involved the delivery system and not the clip itself. Patients who have already received the MitraClip need not worry about this recall, since their procedures were successful.”

Dr. Kodali expects MitraClip procedures will resume once the catheter delivery system is redesigned.

Learn more about MitraClip and the EVEREST study here:
Heart surgery without the surgeon: Researchers test Evalve for non-invasive mitral valve repair“.

* Photo Credit:

*This blog post was originally published at Columbia University Department of Surgery Blog*

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