MitraClip(R) Therapy Data Shows Important Clinical Benefit in High Risk Patients With Functional Mitral Regurgitation at 12-Month Follow Up
EVEREST High-Risk Registry Data Shows Improved Symptomatic Status and Cardiac Function in Functional MR Patients Treated with the MitraClip(R) System
As the most common type of heart valve disease, MR affects more than four million people in
The data were presented today by
“The high-risk registry data in the functional MR patients demonstrate that these patients benefit substantially from the MitraClip(R) therapy,” said Dr. Feldman. “By expanding the options available to these patients, clinical practice will change for the better when this therapy is available in the U.S.”
Patients considered at high-risk for surgery are those with increased likelihood of mortality following surgery, usually because of advanced age and co-morbidities, which limit their treatment options. Without MR reduction, these symptomatic patients have a poor quality of life, are frequently hospitalized for heart failure and have reduced survival.
The FMR high-risk registry cohort was composed of 46 symptomatic patients with grade 3 or 4 MR and at least a 12 percent predicted risk of surgical mortality. Mortality risk was determined by either the Society of Thoracic Surgery Mortality Risk Model, or by a cardiac surgeon’s determination that one or more specifically defined risk factors resulted in a predicted mortality risk of at least 12 percent. The average age was 73 years and most patients had several co-morbidities.
At 12 months, 73 percent of patients with matched data were in NYHA functional class I or II, compared to only 9 percent at baseline. This improvement in functional class was accompanied by improved LV function. The rate of hospitalization for heart failure in the year after treatment with the MitraClip(R) system was significantly (p=0.02) lower than the rate in the year prior to treatment.
“This data from the high-risk registry provides important new information for clinicians in both the US and
About the MitraClip(R) Procedure
Percutaneous mitral repair with Evalve’s MitraClip(R) device is performed by physicians in the catheterization laboratory. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR. After treatment, patients generally recover quickly. The MitraClip(R) device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary.
About Evalve, Inc.
Founded in 1999, Evalve, Inc., headquartered in
The MitraClip(R) system is currently undergoing clinical evaluation in
MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.
Media Contact: Lisa Waters Edelman 1-323-202-1051 Lisa.Waters@edelman.com
SOURCE Evalve, Inc.