Evalve's EVEREST II High-Risk Registry Data Presented

May 20, 2009—Evalve, Inc. (Menlo Park, CA) announced results showing that percutaneous mitral repair using the company's MitraClip system in symptomatic high-risk surgical patients with either functional mitral regurgitation (FMR) or degenerative mitral regurgitation (DMR) improves patient clinical status. The results from the 78-patient EVEREST II High Risk registry demonstrated improvement in left ventricular function and reduced hospitalization for congestive heart failure for both mitral regurgitation groups at 12 months. Additionally, a reduction in mortality compared to the predicted mortality risk of surgery was reported for the registry. Lead investigator Saibal Kar, MD, presented the High-Risk Registry results at the EuroPCR conference in Barcelona, Spain.

According to the company, the High Risk Registry data showed similar 30-day mortality, as well as improved 12-month mortality among patients treated with the MitraClip therapy compared to a concurrent control group who was managed medically or underwent mitral valve surgery. At 12 months, 74% of FMR patients with matched data were in New York Heart Association functional class I or II compared to 9% at baseline. At 12 months, 75% of DMR patients with matched data were in New York Heart Association functional class I or II compared to 15% at baseline. This sustained improvement in functional class was accompanied by improved left ventricular function for both groups. The rate of hospitalization for congestive heart failure in the year after treatment with the MitraClip system was reduced by 55% and significantly lower compared to the year before treatment.

"The High Risk Registry data support our belief that the MitraClip therapy is a safe and clinically beneficial treatment alternative for select patients suffering from significant functional or degenerative mitral regurgitation," commented Dr. Kar. "Patients otherwise unable to withstand more invasive treatments can benefit from the MitraClip therapy while avoiding the risk of increased morbidity and mortality often associated with surgical treatment."