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MitraClip Device Preliminary Data Suggests Improved Heart Function and Relief from Heart Failure Symptoms in Functional Mitral Regurgitation Patients
Date:4/1/2008

Study Continues to Show Lasting Reductions in Mitral Regurgitation Across a

Spectrum of Patients

CHICAGO, April 1, 2008 /PRNewswire/ -- Percutaneous mitral repair using the MitraClip(R) device may successfully reduce mitral regurgitation (MR) in patients suffering from functional MR (FMR) over a two-year period, according to preliminary data from the ongoing Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) presented today at the SCAI Annual Scientific Sessions in Partnership with the ACC i2 Summit (SCAI-ACCi2). The EVEREST trial is evaluating the safety and efficacy of the MitraClip device for the treatment of MR, a condition in which blood leaks backward through the mitral valve, requiring the heart to work harder and ultimately leading to heart failure.

The data analysis was based on 23 patients with moderate-to-severe or severe FMR (grade 3+ to 4+). James Hermiller, M.D., director of the interventional fellowship program at St. Vincent Heart Center of Indiana in Indianapolis, presented the findings. Dr. Hermiller reported that 83 percent of the 23 FMR patients had successful MR reduction after the MitraClip procedure. Additionally, the majority (74 percent) of successfully treated FMR patients showed MR reduction to less than or equal to 2+ MR. Importantly, the MR reduction was maintained, with a Kaplan-Meier durability of MR reduction in 89 percent of patients at one and two years.

"The results have surpassed our initial expectations," said Dr. Hermiller. "This compelling preliminary data suggests that the treatment of functional MR with the MitraClip may be an effective option for patients."

Other results, showed that at one year, clinical symptoms improved or stabilized compared to baseline in 92 percent of successfully treated FMR patients (matched data, n=12). Symptomatic relief was seen in 70 percent of FMR patients who had a history of heart failure.

In addition to the reduction in M
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SOURCE Evalve, Inc.
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