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EVALVE ANNOUNCES INITIATION OF PIVOTAL TRIAL OF PERCUTANEOUS ALTERNATIVE TO OPEN-HEART MITRAL VALVE SURGERY

Patient Randomization Initiated in Nationwide Trial to Demonstrate MitraClip™ Performance for Treatment of Mitral Regurgitation

Positive One-Year Follow-Up Data from EVEREST I Trial presented at TCT Conference Highlights Potential Durability of MitraClip Repair


MENLO PARK, Calif. and WASHINGTON, D.C. -- October 17, 2005 – Evalve, Inc. today announced the successful initiation of the pivotal study, Endovascular Valve Edge-to-Edge REpair STudy (EVEREST) II, a randomized, multi-center study designed to demonstrate the safety and efficacy of its MitraClip™ percutaneous valve repair system for patients with mitral regurgitation (MR).  EVEREST II will compare the MitraClip technique to standard surgical mitral valve repair or replacement in patients with functional or degenerative MR.  Approximately 30 medical centers across North America will be participating in the study.

“We are pleased with the patient outcomes in the EVEREST I study and believe that EVEREST II will demonstrate the effectiveness of the MitraClip for the treatment of mitral regurgitation,” said Ferolyn T. Powell, President and Chief Executive Officer of Evalve.  “The MitraClip is the first percutaneous valve therapy to enter into a randomized, controlled clinical study and it is the only device that is being evaluated for both functional and degenerative MR in the US .  Advancement of this new and less invasive treatment option for patients with MR is a tribute to the dedicated efforts of our clinical investigators and the Evalve team.”

To qualify for the EVEREST II trial, patients must have moderate to severe or severe mitral regurgitation and be experiencing symptoms (fatigue, chest pain, shortness of breath); or, lacking these symptoms, they must have a weakened left ventricle.  The Phase II study is being conducted under a United States Food and Drug Administration (FDA) approved Investigational Device Exemption.

During the procedure, a catheter is introduced through the patient’s skin in the groin area and is then guided through the femoral vein into the affected area of the heart.  A smaller delivery catheter that holds the MitraClip is then introduced through this tube so that the clip can be guided into place and attached to the leaflets (the “swinging doors”) of the mitral valve.  Once the clip is securely attached, it is deployed and the catheters are removed.  The entire process is monitored with echocardiography.  After treatment, patients generally return to normal activity within several weeks.


EVEREST I Results

The Company also announced that positive long-term follow-up results from its initial clinical study, EVEREST I, will be presented at the Cardiovascular Research Foundation’s (CRF) Seventeenth Annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium in Washington , D.C.   These initial results highlight the potential durability of percutaneous mitral valve repair achieved with the Company’s MitraClip device.

The EVEREST I feasibility study has enrolled 47 patients with moderately severe or severe mitral regurgitation who were experiencing symptoms or had a weakened left ventricle.  Only four percent of the 47 patients enrolled experienced a significant adverse event at 30 days.  The first 27 patients treated have reached one-year follow-up.  Ninety-three percent of those patients who experienced a significant reduction in MR at one month following treatment have maintained that improvement at one year.  While all patients required surgery prior to the MitraClip procedure, 75 percent of those who received a clip remain free from surgery.

“These 12-month follow-up results further indicate that this device reduces MR and we are hopeful that the results will continue to be maintained over time.  This will provide a percutaneous option for patients who now require mitral valve surgery to treat their MR,” said EVEREST principal investigator Ted Feldman, MD, director of the cardiac catheterization lab at Evanston Hospital in Evanston , IL .  Dr. Feldman will present the 12-months results on Thurs., Oct. 20, at 1:28 p.m. EDT in Room 151AB of the Washington Convention Center at the TCT Symposium.

The most common type of heart valve insufficiency, MR is a debilitating condition that occurs when the mitral valve, which allows blood to move through the heart, fails to close properly.  An estimated 4 million people in the United States have significant MR, with an annual incidence of 250,000 newly diagnosed patients.  Approximately 50,000 of these patients undergo open heart surgery each year.


About Mitral Regurgitation

Mitral regurgitation (MR) is the most common type of heart valve insufficiency.  It is a debilitating, progressive condition that occurs when the leaflets or “swinging doors" of the mitral valve do not close properly.  The mitral valve is a one-way, blood flow regulator that separates the left atrium, the heart chamber that collects blood, from the left ventricle, the chamber of the heart that pumps blood out to the body.  The failure of the mitral valve to properly close leads to a condition in which a portion of the pumped blood flows back, or regurgitates, through the valve into the left atrium during heartbeats.  Mitral regurgitation results in reduced cardiac output to the body and causes the heart to pump harder to compensate.  If left untreated, the heart becomes damaged and eventually is unable to compensate for the MR, leading to congestive heart failure.  Patients with significant MR may become weakened by their condition and require open-heart surgery to replace or repair the leaking mitral valve.  The two most common causes of MR are valve “degeneration” (so called “floppy valve”), and heart muscle abnormalities caused primarily by coronary artery disease and cardiomyopathy (referred to as “functional” MR).  For more information about mitral regurgitation and the EVEREST II study, please visit www.mitralregurgitation.org and www.evalveinc.com.


About Evalve, Inc.

Evalve was incorporated in 1999 to design, develop, manufacture and market innovative devices, which enable the 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.  Evalve is based in Menlo Park , CA .


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