Interim results of a pilot study using BACE cardiac device released

Sep 25 2009

Mardil, Inc. today announced positive interim data from a pilot study investigating the safety and efficacy of its novel cardiac device - BACE (Basal Annuloplasty of the Cardia Externally) -- in treating mitral valve regurgitation. The condition arises when the heart's mitral valve leaks blood backward into the heart, causing a range of severe and debilitating symptoms.

The first 11 patients implanted with BACE demonstrated a significant reduction in the severity grade of their mitral regurgitation, from a baseline mean grade of 3.32 to a mean grade of 0.61 post implantation, the data demonstrate. Mitral regurgitation severity is graded on a scale from 0 to 4, with 4 representing the most severe condition. The improvements in mitral valve function were sustained at 6 months, as demonstrated by follow-up echocardiograms conducted in the 3 of the 11 patients. No device related adverse events were reported.

Interim results of the 20-patient pilot study were presented today at the annual Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

"While the data are preliminary, they represent a level of improvement that is extremely encouraging," said Jai Raman, MD, PhD, professor of surgery and director of adult cardiac surgery and cardiothoracic surgical research at the University of Chicago. "BACE represents a novel modality for treating functional mitral valve regurgitation because it addresses the root cause of the condition - a heart muscle that is enlarged and weakened - whereas current devices on the market attempt to replace or repair valves that are structurally normal."