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Evalve, Inc. Release: MitraClip(R) Therapy Data Shows Important Clinical Benefit in High Risk Patients With Functional Mitral Regurgitation at 12-Month Follow Up


3/29/2009 10:39:31 PM

EVEREST High-Risk Registry Data Shows Improved Symptomatic Status and Cardiac Function in Functional MR Patients Treated with the MitraClip(R) System

ORLANDO, Fla., March 28 /PRNewswire/ -- Percutaneous mitral valve repair using the MitraClip(R) system in symptomatic high-risk surgical patients with functional mitral regurgitation (FMR) improves patient clinical status, and left ventricular function, according to 12-month data from the high-risk registry arm of the EVEREST II (Endovascular Valve Edge-to-Edge REpair STudy) study presented today at the 58th Annual Scientific Session of the American College of Cardiology (ACC) i2 Summit Scientific Sessions.

As the most common type of heart valve disease, MR affects more than four million people in the United States, the majority of which have FMR. There are 250,000 new diagnoses of significant MR each year; however only 20 percent, or approximately 50,000, of these patients undergo surgery each year. Many higher risk surgical patients and non-surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, and may ultimately lead to heart failure.

The data were presented today by Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston North Shore Hospital and co-principal investigator of the EVEREST trials.

"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 Europe as they consider treatment with the MitraClip(R) therapy for high risk patients with severe MR," said Ferolyn Powell, president and chief executive officer of Evalve. "This new data illustrates the benefit the MitraClip(R) therapy provides to those patients who are not good candidates for surgery. It also adds to the evidence demonstrating the benefit of the MitraClip(R) therapy for patients with Functional MR who currently often have limited surgical options. The observed decrease in hospitalization for heart failure in this population could have an important health-economic impact."

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 Menlo Park, Calif., has developed a proprietary system which enables percutaneous repair of cardiac valves. The company's initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. For more information about Evalve, Inc., and for an animated explanation of the procedure using the MitraClip(R) device, visit www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (www.thefoundry.com).

The MitraClip(R) system is currently undergoing clinical evaluation in the United States and Canada. Enrollment is ongoing in the REALISM study which allows EVEREST investigators and their patients continued access to the MitraClip(R) therapy. The MitraClip(R) system is available for commercial distribution in the EU.

MitraClip(R) and Evalve are registered trademarks of Evalve, Inc.

CONTACT: Lisa Waters of Edelman, +1-323-202-1051, Lisa.Waters@edelman.com,
for Evalve, Inc.

Web site: http://www.evalveinc.com/



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