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MEDICAL DEVICE INNOVATION - Medical Device Daily

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80<br />

Mardil offers ‘heart-y’ hug<br />

system to treat mitral valve<br />

By DON LONG<br />

<strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong> National Editor<br />

Everybody needs a hug. And many people, primarily<br />

heart patients who are experiencing mitral valve regurgitation,<br />

need it more than others.<br />

That’s the foundation concept for a new device system,<br />

being developed by developmental firm Mardil (Haifa,<br />

Israel/Morrisville, North Carolina), intended to correct<br />

mitral valve regurgitation, a condition in which blood leaks<br />

through the valve, from the left ventricle into the left atrium<br />

of the heart, greatly reducing its efficiency and producing<br />

the debilitating symptoms of congestive heart failure.<br />

The company, founded two years ago and with its roots<br />

in Israel, has just reported the launch of first-in-man clinical<br />

trials of its Basal Annuloplasty of the Cardia Externally<br />

device (or BACE), as a way of squeezing the heart as a<br />

method for improving the function of the mitral valve.<br />

The first patient in Mardil’s 20-patient pilot study was<br />

implanted with the BACE device last month in India. The<br />

company reported that the patient had a significant<br />

improvement in heart function after the procedure.<br />

Gopal Muppirala, the company’s CEO based in the U.S.,<br />

told <strong>Medical</strong> <strong>Device</strong> <strong>Daily</strong> that improved function can be<br />

determined even before the implantation of the BACE<br />

device is completed, with the use of a real-time echocardiogram.<br />

The device consists of what Muppirala called four<br />

“chambers,” essentially inflatable silicone-wrapped, which<br />

are placed around the heart and then used to apply pressure<br />

by squeezing the muscles and other tissues around<br />

the mitral valve – in essence, giving it a hug – so that the<br />

valve performs more efficiently and shuts off the damaging<br />

leakage of blood.<br />

Muppirala said that one of the chief benefits of the<br />

BACE device is that it offers an alternative, in a majority of<br />

mitral valve cases, for those patients with a valve so damaged<br />

that it needs replacement.<br />

These chambers, in the system’s first iteration, are<br />

placed during an open surgical procedure which does not<br />

require stopping the heart. And Muppirala said that the<br />

company is working to develop methodology for implantation<br />

via a cardio-thoracotomy, a much less invasive procedure.<br />

Once placed around the heart, the chambers are filled<br />

with saline, exerting variable amounts of pressure, with the<br />

surgeon able to make the necessary adjustments of that<br />

pressure. As the heart alters its function, the pressure of<br />

these chambers can then be changed in follow-up adjustments.<br />

No cannula for access into the body is needed to do<br />

this, Muppirala said. Salilne can simply be injected through<br />

<strong>MEDICAL</strong> <strong>DEVICE</strong> <strong>INNOVATION</strong> 2010<br />

the skin into a tube running under the skin and providing<br />

access to the four chambers.<br />

Muppirala emphasized that the device is not intended<br />

to treat patients that have valves that are defective in structure<br />

as a result of disease or faulty architecture; defective<br />

valves will continue to be addressed by valve replacement,<br />

he said.<br />

Rather, the BACE system addresses those conditions in<br />

which the valve can work properly but the heart lacks the<br />

necessary strength to make it work effectively.<br />

He said that this target pool – citing his conversations<br />

with cardiovascular surgeon experts in the field – may be<br />

up to 2 million patients in the U.S. and outnumbers those<br />

with problems as the result of a valve that is diseased or<br />

badly misshapen.<br />

Muppirala told MDD that the company is hoping to file<br />

for an investigational device exemption with the FDA in<br />

August or September, and that the company recently met<br />

with the FDA to begin hammering out details for the protocol<br />

of the IDE study.<br />

With approval of the IDE, Mardil plans to launch a multinational<br />

clinical trial in the U.S., Canada, Israel, Australia and<br />

Europe in the fall of this year.<br />

“Mardil’s concept is truly revolutionary in its approach<br />

in that the device simultaneously treats valvular dysfunction<br />

while supporting the weakened ventricular muscle, the<br />

latter of which is not being adequately addressed by the<br />

current therapies on the market,” said Lishan Aklog, MD,<br />

chief of cardiovascular surgery at St. Joseph’s Hospital<br />

(Phoenix).<br />

Mardil is emphasizing the much less invasive approach<br />

to the problem of regurgitation, and the avoidance of the<br />

risks of open surgery for valve replacement. It cites a mortality<br />

rate of up to 10% for patients undergoing a mitral<br />

valve repair in conjunction with coronary artery bypass<br />

surgery. The BACE device was pioneered by Jai Raman, MD,<br />

a cardiovascular surgeon attempting to develop a less risky<br />

strategy for this therapy.<br />

A professor of surgery and director of adult cardiac<br />

surgery and cardiothoracic surgical research at the<br />

University of Chicago, Raman said that the system is “the<br />

next-generation treatment for mitral valve regurgitation”<br />

because it addresses “the root cause of the condition, a<br />

heart muscle that is weakened, stretched and enlarged.<br />

BACE corrects the functional abnormality that leads to<br />

mitral regurgitation, whereas current devices on the market<br />

focus on replacing or repairing valves that are structurally<br />

normal.”<br />

Muppirala said that besides avoiding the side effects<br />

and potential mortality associated with valve replacement,<br />

the system can be offered at much reduced cost.<br />

He said that the company was launched with seed<br />

funding from venture capital funds out of India and that it<br />

currently is on the look-out to raise an additional $20 million<br />

to carry it through the planned multinational clinical<br />

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Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.

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