New data shows benefits of MitraClip for patients with mitral reg...( WASHINGTON D.C. Oct. 24 2007 The va...)

WASHINGTON, D.C., Oct. 24, 2007 The vast majority of patients who had a successful result with the percutaneous MitraClip device did not need mitral valve surgery three years after their procedure, and many benefited from significantly improved function of the left ventricle (commonly known as reverse remodeling), according to data presented this week at the Cardiovascular Research Foundations (CRF) nineteenth annual Transcatheter Cardiovascular Therapeutics (TCT) symposium in Washington, D.C.

During multiple sessions at TCT 2007, researchers participating in the EVEREST II study presented data from a 107-person, non-randomized patient registry. The presentations evaluated the reduction of mitral regurgitation severity with the MitraClip device and the positive impact of this reduction for patients. The ongoing randomized study arm of EVEREST II is evaluating the safety and efficacy of the MitraClip device compared to surgical mitral valve repair or replacement for the treatment of mitral regurgitation (MR; a condition in which blood leaks backward through the mitral valve with each heartbeat, causing the heart to work harder to circulate oxygen to the body). Highlights of the data presented this week include:

36 Month Follow-up Shows Ongoing Effectiveness and Durability

• 82 percent of patients who had a successful result with the MitraClip device remain free from surgery 36 months after the procedure.

Reduction in Mitral Regurgitation Severity

• 74 percent of patients with one or more Clips implanted experienced a reduction to ≤ Grade 2+ MR as assessed by the EVEREST Core Laboratory and graded per the American Society of Echocardiography guidelines.

Significant Reverse Remodeling of the Left Ventricle

• 12 months after a successful MitraClip procedure, significant reverse remodeling of the left ventricle was demonstrated. Reverse remodeling was assessed based
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