Mardil’s pilot study: positive data

SAN FRANCISCO, Sept. 24, 2009 /PRNewswire/ — Mardil Medical 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.”

About the study

The pilot study of 20 patients was designed to assess the safety and efficacy of the BACE Device, a less invasive cardiac device that sits outside the heart and supports the weakened ventricular muscle while treating valvular dysfunction. Eleven patients with moderate to severe ischemic mitral regurgitation underwent implantation with BACE, along with coronary artery bypass grafting (CABG) on a beating heart; seven of them underwent surgery without a heart-lung bypass machine. Three patients had left ventricular reconstructive procedures. One patient died of complications related to insertion of a mechanical support device that was placed pre-operatively. No device-related adverse reactions were reported in the trial.

The pilot study is being conducted in India. Mardil is seeking an investigational device exemption (IDE) through the U.S. Food and Drug Administration to begin clinical trials in the U.S. next year.

About BACE

The BACE Device serves as a tension band that encircles the exterior of the heart, supporting the left ventricular wall and the mitral valve annulus. Gentle pressure and support from the BACE Device allow the leaflets of the mitral valve to close properly, thereby preventing blood from leaking backward when the heart pumps. BACE is the only device that can be adjusted and fine-tuned after implantation and in an office setting. The device was designed to reduce the significant mortality and morbidity rates associated with current treatments for mitral valve repair and replacement. The device sits outside the heart, negating the need for open-heart surgery or the use of a heart-lung bypass machine, both of which pose serious risks and side effects.