RESEARCH TRIANGLE PARK, N.C., Jan. 26 /PRNewswire/ -- Mardil Inc., a cardiac device company with novel technology for treating mitral valve regurgitation, has successfully advanced its device to first-in-human testing, a milestone achievement for the 2-year-old company.
The first patient was successfully implanted with the Mardil device last month in India. The patient had a significant improvement in heart function after the procedure, according to preliminary data from a 20-patient pilot study. Pending U.S. Food and Drug Administration approval of the clinical protocol, Mardil will launch a multinational clinical trial in the U.S., Canada, Israel, Australia and Europe in the fall of 2009.
"Mardil's concept is truly revolutionary in its approach in that the device simultaneously treats valvular dysfunction while supporting the weakened ventricular muscle, the latter of which is not being adequately addressed by the current therapies on the market," said Dr. Lishan Aklog, chief of cardiovascular surgery at St. Joseph's Hospital in Phoenix, Ariz.
Mitral regurgitation occurs when the mitral valve leaks blood backward into the heart, a condition that often leads to congestive heart failure and severe, debilitating symptoms. Current treatments for the condition, however, carry a range of serious complications and risks.
The average mortality rate for patients undergoing mitral valve repair and coronary artery bypass surgery together has risen to 10 percent, a statistic that Mardil founders hope to reduce with their device.
The Mardil device, called BACE(TM) (Basal Annuloplasty of the Cardia Externally), was pioneered by cardiothoracic surgeon Dr. Jai Raman in his efforts to develop a minimally invasive approach to treating mitral regurgitation.
"We designed BACE to reduce the significant costs, side effects and mortality rates associated with current mitral valve repair and repla
|SOURCE Mardil Inc.|
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