MitraClip(R) Therapy Data Demonstrate Clinical Benefit in High-Risk Patients With Mitral Regurgitation

BARCELONA, Spain - EVEREST High-Risk Registry Data Show Improved Symptomatic Status, Cardiac Function and Reduced rate of Hospitalization for Congestive Heart Failure in both Functional and Degenerative MR Patient Populations

Results show percutaneous mitral repair using the MitraClip(R) 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 MR groups at twelve months. Additionally, a reduction in mortality compared to the predicted mortality risk of surgery was reported for the registry. The results of the High-Risk Registry were presented today at the third annual meeting of EuroPCR, the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

MR is the most common type of heart valve insufficiency in Europe and the United States, affecting millions of people worldwide. Significant MR affects more than eight million people in the US and Europe, the majority of which have FMR. There are more than 600,000 new diagnoses of significant MR each year in Europe and the US; however only 20 percent 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 Saibal Kar, M.D., director of interventional cardiac research at Cedars-Sinai Medical Center and the lead enrolling investigator of the EVEREST trials.

“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 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 decreasing re-hospitalizations for congestive heart failure in this population. With more than 500 MitraClip cases performed worldwide, these findings add to the evidence from the US and Europe that indicates the MitraClip therapy may offer a minimally invasive alternative to reduce chronic volume overload caused by MR, while preserving traditional therapeutic options in selected patients.”

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.

Source: Evalve, Inc.

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