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remodeling of the left ventricle was demonstrated. Reverse remodeling
was assessed based on five echocardiographic measures, including left
ventricular end-systolic dimension.
-- In line with the reverse remodeling, 94 percent of patients who had a
successful result with the MitraClip device had improved or stable New
York Heart Association (NYHA) Class at 12 months following the
procedure.
"Our work to reduce mitral regurgitation with a percutaneous approach continues to produce compelling results," said Ted Feldman, M.D., who presented the 36 month follow-up data at TCT. Dr. Feldman is the EVEREST II national co-principal investigator and director of the cardiac catheterization lab at Evanston Northwestern Healthcare in Evanston, Illinois. "The reduction in MR severity achieved, along with the stability of the results at 36 months and the preservation of subsequent surgical options, leads us to believe that the MitraClip device is likely to become a viable first-line option for treating MR in many patients."
Dr. Michael Rinaldi, who presented the reverse remodeling data at TCT, concurred. "The reverse remodeling data is important in that it provides compelling, objective evidence that the MitraClip device is having a positive impact on patients," said Dr. Rinaldi, director of clinical research at Sanger Clinic/Carolinas Medical Center. "Additionally, patients with the MitraClip report that they feel better and are able to engage more fully in activities they enjoy."
EVEREST Study Continues Enrollment
The EVEREST study continues at more than 35 centers in North America,
with more than 300 patients enrolled and more than 300 MitraClip devices
implanted to date. Investigators are currently enrolling patients in both
arms of the EVEREST II study -- a randomized, controlled arm and a high
risk registry arm -- with the goal of completing
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