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Data Show Clinical Benefit From Mitral Valve Clip Device

September 21, 2010

A percutaneous mitral valve clip designed to stop mitral valve regurgitation demonstrated clinical benefit as measured by the degree of mitral regurgitation, according to a study presented at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. Mitral valve regurgitation is one of the most common forms of heart disease.

The study was led by James Hermiller, MD, Director of Cardiovascular Intervention at the St. Vincent Heart Center of Indiana (Indianapolis, IN.)

“Significant measures of clinical benefit are observed one year following successful therapy,” said Dr. Hermiller.

The study, EVEREST II, is a prospective, multi-center, randomized controlled trial designed to compare the safety and effectiveness of the MitraClip System with mitral valve surgery in the treatment of mitral regurgitation (MR). Measures of 12-month clinical benefit, defined as improvements in left ventricular (LV) function and symptomatic improvement, were evaluated for the Device Group and Control Group, and have been previously reported. However, observed clinical benefit by 12 month MR grade has not been reported.

Significant improvement in LV function, NYHA Functional Class, and Quality of Life scores was observed for all device patients with ongoing success (MR⓰¤2+ at 12 months). Patients with MR reduced to 1+, 1+ to 2+, or 2+ at 12 months demonstrated marked clinical benefit, with significant improvements noted from baseline to 12 months.

A detailed analysis of these data will be presented during The ‘Best of the Best’ TCT 2010 Abstracts Session at 3:16 PM on Friday, September 24 in the Main Arena at the Washington Convention Center.

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