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MitraClip(R) Therapy Data Demonstrate Clinical Benefit in High-Risk Patients With Mitral Regurgitation
Date:5/20/2009

ficial treatment alternative for select patients suffering from significant functional or degenerative MR," said 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."

Patients considered at high-risk for surgery are those with an increased likelihood of mortality and morbidity following surgery, usually because of advanced age and co-morbidities, which consequently limit their treatment options. Without MR reduction, these patients have a poor quality of life, are frequently hospitalized for heart failure and have reduced survival.

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 percent of FMR patients with matched data were in NYHA functional class I or II, compared to only 9 percent at baseline. Similarly, at 12 months, 75 percent of DMR patients with matched data were in NYHA functional class I or II, compared to only 15 percent at baseline. This sustained improvement in functional class was accompanied by improved LV 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 percent and significantly lower compared to the year prior to treatment.

"The high-risk registry data carries healthcare implications from both a quality of life and an economic perspective," said Ferolyn Powell, president and chief executive officer of Evalve. "It suggests the MitraClip therapy may be a good treatment alternative for patients with MR who are too high risk for surgery and also indicates the therapy potentially reduces healthcare costs by
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SOURCE Evalve, Inc.
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