CLINICAL TRIALS
Everest II Clinical Trial for Patients with Mitral Regurgitation
About Evalve, Inc.
Evalve was incorporated in 1999 to design, develop, manufacture and market innovative devices to enable percutaneous (catheter-based) 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.
An estimated 4 million people in the United States have significant mitral valve insufficiency, with an annual incidence of 250,000. Approximately 50,000 of these patients undergo surgery each year. Valve insufficiency, ifleft untreated, is associated with chronic volume overload, which ultimately leads to atrial fibrillation, heart muscle dysfunction, symptoms of congestive heart failure (CHF) and an increased risk of sudden death.
Improved treatment options for people with valvular insufficiency may reduce the potential for developing CHF and may improve the quality of life for those currently suffering from CHF.
Evalve is sponsoring clinical trials in order to secure regulatory approval
from the FDA (Food and Drug Administration). Evalve is nearing completion of
a Phase I IDE clinical trial (called EVEREST I, an acronym for Endovascular Valve Edge-to-Edge REpair STudy),
an initial study conducted between July 2, 20.03 and present date. The purpose
of EVEREST I was to demonstrate the safety and feasibility of use of the Evalve
procedure to treat patients with Grade 3 (moderate to severe) or Grade 4 (severe)
mitral regurgitation. The study took place at 12 medical centers located in
the U.S. and a total of 44 patients underwent the Evalve procedure to date.
For more information please contact:
St. Patrick Hospital
500 W. Broadway
Missoula, MT 59802
Mark Sanz, MD (Investigator)
Interventional Cardiologist
Heidi Boehm (Coordinator)
Phone: 406-329-2717
Email: boehm@saintpatrick.org
Website: www.evalveinc.com
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