Evalve Announces CE Mark Approval of the World’s First Percutaneous Valve Repair System
Menlo Park, CA, March 25, 2008 - Evalve, Inc., the leader in the development of devices for the percutaneous repair of cardiac valves, announced today CE Mark approval for its MitraClip® system. The MitraClip is the first commercially available device which enables a non-surgical option for patients suffering from the effects of mitral regurgitation (MR).
MR is the most common type of heart valve insufficiency in the United States and the second most common in Europe, affecting millions of people worldwide. Both in the United States and Europe, the vast majority of patients 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.
CE Mark approval gives Evalve the ability to train and educate physicians in Europe on the use of the MitraClip device increasing the number of patients who will potentially benefit from this innovative treatment. Evalve will work with hospitals across Europe to establish training programs which will allow physicians to gain access to this new technology.
In addition to CE Mark approval, company highlights include:
- High Risk Registry Study Arm Enrollment Completed: Evalve recently completed enrollment in the high-risk registry arm of the Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) in North America. Patients who are high risk surgical candidates may benefit from a less invasive procedure. Investigators are collecting follow-up data to assess the risk-benefit profile from the less invasive percutaneous intervention with the MitraClip device.
- Continued Progress with EVEREST Trial: The EVEREST investigators from more than 40 sites across North America have reached additional milestones in the ongoing FDA-approved Phase II clinical study. EVEREST Investigators have treated more than 300 patients with close to 400 MitraClip devices implanted. Trial data continues to grow with a significant amount of three-year follow up results available as well as four-year data from some patients.
- Presentation of MitraClip Procedure Results: Data regarding the results in functional MR (ischemic and cardiomyopathy) patients will be presented by James Hermiller, M.D., director of the interventional fellowship program at St. Vincent Heart Center of Indiana in Indianapolis, at the SCAI-ACCi2 annual meeting in Chicago as part of the late-breaking clinical trial program on Tuesday, April 1. In addition to the data presentation, Evalve is sponsoring a breakfast symposium organized by SCAI on Monday, March 31 where MitraClip device data will be reviewed. The “Understanding Mitral Regurgitation” symposium is being chaired by Ted Feldman, M.D., national principal interventional cardiology investigator for the EVEREST study.
“The progress we have made, notably the milestones achieved in the EVEREST trial and receiving CE Mark approval, are important as we move toward commercialization in Europe and the U.S.,” said Ferolyn Powell, President and Chief Executive Officer of Evalve. “We believe the MitraClip system has the potential to benefit patients who currently suffer from the serious effects of MR. Oftentimes patients in consultation with their doctors choose not to undergo surgical treatment because of the associated risks and trauma. However, until now surgery was the only available treatment option. The MitraClip offers the patients a new alternative.”
EVEREST investigators are currently enrolling patients in the randomized arm of the study with the goal of completing enrollment by the end of 2008.
Enrollment in the study is open to several patient groups:
- Patients with either degenerative or functional MR
- Patients who are good surgical candidates and are open to the option of a less invasive approach
- Patients who are higher risk surgical candidates but are considered operable
More information about the EVEREST trial is available at www.mitralregurgitation.org
About the MitraClip Procedure
Percutaneous mitral repair with Evalve’s MitraClip device is performed by interventional cardiologists 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.
Evalve, Inc. (Menlo Park, Calif.) was incorporated in 1999 to design, develop, manufacture, and market innovate devices to enable 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. The company’s present development and clinical efforts are focused on mitral valve repair. For more information about Evalve, Inc., and for an animated explanation of the Percutaneous Mitral Repair procedure using the MitraClip device, visit www.evalveinc.com. Evalve is the first portfolio company from the medical device company incubator, The Foundry (www.thefoundry.com).
MitraClip and Evalve are registered trademarks of Evalve, Inc.