Novel Device for Mitral Valve Regurgitation Advances to First-In-Human Trials
January 27, 2009 - Mardil Inc., a cardiac device company with novel technology for treating mitral valve regurgitation, has successfully advanced its device to first-in-human testing, the company announced yesterday.
The first patient successfully implanted with the Mardil device last month in India showed a significant improvement in heart function after the procedure, according to preliminary data from a 20-patient pilot study. Pending FDA 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 Lishan Aklog, M.D., chief of cardiovascular surgery at St. Joseph's Hospital in Phoenix, AZ.
The Mardil device, known as BACE (Basal Annuloplasty of the Cardia Externally), was pioneered by cardiothoracic surgeon Jai Raman, M.D., in his efforts to develop a minimally invasive approach to treating mitral regurgitation.
According to Dr. Raman, BACE represents a departure from current devices because it addresses the root cause of the condition: a heart muscle that is weakened, stretched and enlarged. Dr. Raman is professor of surgery and director of adult cardiac surgery and cardiothoracic surgical research at the University of Chicago.
"The Mardil device is the next-generation treatment for mitral valve regurgitation," said Dr. Raman. "BACE corrects the functional abnormality that leads to mitral regurgitation, whereas current devices on the market focus on replacing or repairing valves that are structurally normal."
BACE reportedly can be remotely adjusted through ports under the skin that funnel saline to and from four inflatable chambers built into the tension band. The efficacy of BACE can be assessed at the time of implantation through a real-time echocardiogram, allowing for immediate adjustments in pressure.
The company is now finalizing its multinational clinical trial protocol for submission to the FDA this summer.
For more information: www.mardil.com
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