Medical Device Daily National Editor

Everybody needs a hug. And many people, primarily heart patients who are experiencing mitral valve regurgitation, need it more than others.

That's the foundation concept for a new device system, being developed by developmental firm Mardil (Haifa, Israel/Morrisville, North Carolina), intended to correct mitral valve regurgitation, a condition in which blood leaks through the valve, from the left ventricle into the left atrium of the heart, greatly reducing its efficiency and producing the debilitating symptoms of congestive heart failure.

The company, founded two years ago and with its roots in Israel, has just reported the launch of first-in-man clinical trials of its Basal Annuloplasty of the Cardia Externally device (or BACE), as a way of squeezing the heart as a method for improving the function of the mitral valve.

The first patient in Mardil's 20-patient pilot study was implanted with the BACE device last month in India. The company reported that the patient had a significant improvement in heart function after the procedure.

Gopal Muppirala, the company's CEO based in the U.S., told Medical Device Daily that improved function can be determined even before the implantation of the BACE device is completed, with the use of a real-time echocardiogram.

The device consists of what Muppirala called four "chambers," essentially inflatable silicone-wrapped, which are placed around the heart and then used to apply pressure by squeezing the muscles and other tissues around the mitral valve – in essence, giving it a hug – so that the valve performs more efficiently and shuts off the damaging leakage of blood.

Muppirala said that one of the chief benefits of the BACE device is that it offers an alternative, in a majority of mitral valve cases, for those patients with a valve so damaged that it needs replacement.

These chambers, in the system's first iteration, are placed during an open surgical procedure which does not require stopping the heart. And Muppirala said that the company is working to develop methodology for implantation via a cardio-thoracotomy, a much less invasive procedure.

Once placed around the heart, the chambers are filled with saline, exerting variable amounts of pressure, with the surgeon able to make the necessary adjustments of that pressure. As the heart alters its function, the pressure of these chambers can then be changed in follow-up adjustments.

No cannula for access into the body is needed to do this, Muppirala said. Salilne can simply be injected through the skin into a tube running under the skin and providing access to the four chambers.

Muppirala emphasized that the device is not intended to treat patients that have valves that are defective in structure as a result of disease or faulty architecture; defective valves will continue to be addressed by valve replacement, he said.

Rather, the BACE system addresses those conditions in which the valve can work properly but the heart lacks the necessary strength to make it work effectively.

He said that this target pool – citing his conversations with cardiovascular surgeon experts in the field – may be up to 2 million patients in the U.S. and outnumbers those with problems as the result of valve that is diseased or badly misshapen.

Muppirala told MDD that the company is hoping to file for an investigational device exemption with the FDA in August or September, and that the company recently met with the FDA to begin hammering out details for the protocol of the IDE study.

With approval of the IDE, Mardil plans to launch a multinational clinical trial in the U.S., Canada, Israel, Australia and Europe in the fall of this year.

"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, MD, chief of cardiovascular surgery at St. Joseph's Hospital (Phoenix).

Mardil is emphasizing the much less invasive approach to the problem of regurgitation, and the avoidance of the risks of open surgery for valve replacement. It cites a mortality rate of up to 10% for patients undergoing a mitral valve repair in conjunction with coronary artery bypass surgery.

The BACE device was pioneered by Jai Raman, MD, a cardiovascular surgeon attempting to develop a less risky strategy for this therapy.

A professor of surgery and director of adult cardiac surgery and cardiothoracic surgical research at the University of Chicago, Raman said that the system is "the next-generation treatment for mitral valve regurgitation" because it addresses "the root cause of the condition, a heart muscle that is weakened, stretched and enlarged. 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."

Muppirala said that besides avoiding the side effects and potential mortality associated with valve replacement, the system can be offered at much reduced cost.

He said that the company was launched with seed funding from venture capital funds out of India and that it currently is on the look-out to raise an additional $20 million to carry it through the planned multinational clinical trial.

At least two other companies are pursuing the "hugging" strategy for strengthening the heart. Acorn Cardiovascular (St. Paul, Minnesota) has developed the CorCap, a mesh wrap implanted around the heart to provide ventricular support.

And Paracor (Sunnyvale, California) has developed the HeartNet, calling it "super-elastic" nitinol wrapping placed around the heart to prevent the additional enlargement resulting from congestive heart failure.