MENLO PARK, Calif., Feb. 2 /PRNewswire/ -- Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today the start of enrollment in the REALISM (Real World ExpAnded MuLtIcenter Study of the MitraClip(R) System) study, a continued access registry. The MitraClip(R) system is currently being evaluated in the United States as a non-surgical treatment option for patients suffering from the effects of mitral regurgitation (MR). EVEREST II, the only randomized trial comparing a percutaneous mitral repair device to mitral valve surgery, successfully completed enrollment in 2008.
MR affects millions of people worldwide and is the most common type of heart valve insufficiency in the United States and Europe. The vast majority of patients with significant MR are untreated, which leaves their hearts affected by the chronic volume overload caused by MR, requiring the heart to work harder, and ultimately leading to heart failure.
The first patient was enrolled in REALISM by Peter Fail, M.D., and his team at Terrebonne Regional Medical Center in Houma, Louisiana.
"Based on my experience treating patients with the MitraClip(R) system during EVEREST II, I am eager to participate in the REALISM study," said Dr. Fail, director of the cardiac catheterization lab and principal investigator at Terrebonne Regional Medical Center. "I often see patients who may be candidates for the MitraClip(R) therapy and I am glad they now have an option to participate in the continuation of this landmark trial and potentially benefit from this alternative treatment."
The REALISM study is a prospective, multi-center, continued access registry of the EVEREST II study. The REALISM study consists of two arms: a high risk arm and a non-high risk arm. Up to 300 patients will be enrolled in the study at clinical sites in the United States. Patients will undergo 30- day, 6-month and 12-month clinical follow-up. REALISM will collect new information regarding functional capacity following treatment with the MitraClip(R) device.
"The REALISM study will allow patients suffering from the effects of MR to continue to have access to the MitraClip(R) therapy under a controlled protocol while data from the EVEREST II trial are being finalized," said Ted Feldman, M.D., director of the cardiac catheterization lab at Evanston Hospital and co-principal investigator of the EVEREST trial. "This will also allow us to observe the use of the MitraClip(R) system under real world conditions and will allow us to further study changes in functional capacity after successful treatment with the MitraClip(R) system."
"Initiating enrollment in REALISM is an important milestone for Evalve," said Ferolyn Powell, president and chief executive officer of Evalve. "REALISM allows participating EVEREST investigators continued access to the MitraClip(R) therapy for patients suffering from MR. As we make progress toward filing the MitraClip(R) system premarket approval application with the FDA, this study also allows physicians to gain additional experience with the system and enables patients to potentially benefit from a less invasive treatment option."
The MitraClip(R) system is the only commercially available treatment option for non-surgical mitral valve repair in Europe.
About the MitraClip(R) Procedure
Percutaneous mitral repair with Evalve's MitraClip(R) system 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) therapy 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 procedure using the MitraClip(R) 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(R) system is currently undergoing clinical evaluation in the United States and Canada.
MitraClip(R) and Evalve(R) are registered trademarks of Evalve, Inc.
CONTACT: Amy Hytowitz of Edelman, +1-323-202-1028,
amy.hytowitz@edelman.com, for Evalve, Inc.
Web site: http://www.evalveinc.com/
http://www.thefoundry.com/
