September 30, 2008
Evalve Announces Enrollment Completion of the EVEREST Randomized Study
MENLO PARK, Calif., Sept. 30 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today the completion of randomized enrollment in the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST), which is evaluating the MitraClip(R) system as a non-surgical repair option for patients suffering from mitral regurgitation (MR). MR is the most common type of heart valve insufficiency in the United States, affecting millions of people worldwide.
"The completion of enrollment in the randomized trial is an important milestone for the field of cardiology," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Northwestern Hospital and co-principal investigator of the trial. "It is the first randomized trial of any percutaneous mitral repair device compared to mitral valve surgery, and also the first large prospective evaluation of current mitral valve surgery using an independent core laboratory."EVEREST is a U.S. Food and Drug Administration (FDA) approved Phase II randomized, controlled, multi-center clinical research study in the United States and Canada evaluating the safety and efficacy of the MitraClip device in 279 patients with moderate-to-severe (3+) or severe (4+) MR, as compared to surgical repair or replacement. The study effectiveness endpoint requires an MR reduction to less than or equal to 2+ at one year. The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate-to-severe or severe mitral regurgitation at 12 months. The primary safety endpoint is freedom from major adverse events (MAE) at 30 days or hospital discharge whichever is longer.
Evalve received CE Mark approval for the MitraClip device earlier this year and the first series of patients were recently treated in Germany. The MitraClip system is the only commercially available treatment alternative that enables non-surgical repair for MR.
"Randomized trials provide valuable insight into directing future studies to improve therapy and match new therapies to the appropriate patient," said Donald Glower, M.D., professor of surgery at Duke Medical Center and co-principal investigator of the EVEREST study. "This trial sets a high scientific standard for future percutaneous valve therapies. As a result, this trial will have a significant and long-lasting impact on patient care around the world."
Overall, EVEREST Investigators have treated more than 350 patients with over 450 MitraClip devices implanted. Clinical data continues to grow and a significant number of three-year follow up results are available as well as four-year data from a smaller group of patients.
Registry data from the initial non-randomized cohort of EVEREST patients continue to indicate MR reduction is maintained over time in the majority of patients, hospital stays are short, fewer complications occur compared to mitral valve surgery and surgical options are preserved if needed.
More information about the EVEREST trial is available at http://www.mitralregurgitation.org/.
"This is an important achievement for Evalve on the path to meeting regulatory milestones with the FDA," said Ferolyn Powell, president and chief executive officer of Evalve. "We believe the MitraClip system has the potential to provide patients suffering with MR an important alternative to surgery that will allow them to avoid the associated risks and trauma."
About the MitraClip Procedure
Percutaneous mitral repair with Evalve's MitraClip 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 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, California -- 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 percutaneous mitral repair procedure using the MitraClip device, visit http://www.evalveinc.com/. Evalve is the first portfolio company from the medical device company incubator, The Foundry (http://www.thefoundry.com/).
The MitraClip system is currently undergoing clinical evaluation in the United States and Canada.
MitraClip and Evalve are registered trademarks of Evalve, Inc.
CONTACT: Heather Harper of Edelman, +1-415-486-3233,[email protected], for Evalve, Inc.
Web site: http://www.evalveinc.com/