"We have seen procedural success in the majority of patients treated with the MitraClip(R) system," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston North Shore Hospital, co-principal investigator of the EVEREST trial and lead author of the JACC manuscript. "The results we've seen expand the range of options available to patients affected by MR, especially for people who are not good candidates for surgery or who want to avoid the risks of a surgical procedure."
The study population included 107 registry patients with moderate-to-severe (grade 3+) or severe (grade 4+) MR who were candidates for mitral valve surgery. Of these patients, 79 percent had degenerative MR and 21 percent had functional MR. Among patients with functional MR, 74 percent had a history of coronary artery disease and 43 percent had prior bypass surgery.
At baseline, patients either presented with symptoms or when without symptoms, they had compromised left ventricular (LV) function, as defined by an ejection fraction less than 60 percent or a systolic ventricular size greater than 40 mm.
Transthoracic echocardiography was performed at baseline, pre-discharge, and at one, six, twelve months, and yearly thereafter up to five years. The data was analyzed by an independent echocardiographic core laboratory at the University of California, San Francisco under the direction of Elyse Foster, M.D.
"These data, along with experience in the REALISM continued access study in the U.S. and the commercial experience in Europe, continue to build a strong body of evidence in support of establishing the MitraClip(R) therapy as a viable option for select patients with functional or degenerative MR," said Ferolyn Powell, president and chief executive officer of Evalve. "We have seen excellent safety and notable procedural succ
|SOURCE Evalve, Inc.|
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