First Human Implants of Mardil Medical’s Ventricular Reshaping Device Occur in Malaysia

Doctors in Malaysia have performed the first implants of Mardil Medical Inc.’s VenTouch Ventricular Reshaping Device at the Institut Jantung Negara (IJN) National Heart Institute in Kuala Lumpur, Malaysia. The investigational device was implanted in two patients with severe functional mitral valve regurgitation (FMR), which was reduced to only trace amounts after implantation. The patients are part of a multi-center, global clinical study.

Jeswant Dillon, M.D., clinical director of Adult Surgery and Mohd Azhari Yakub, M.D., chief cardiothoracic surgeon, performed the implantations at IJN. The first patient presented several challenges due to severe FMR combined with significant heart dilation and poor left ventricular function.

“After implantation of the VenTouch Systems’ therapy device the patient’s mitral valve regurgitation was reduced to trace amounts and the patient was moved out of the intensive care unit the following day,” said Dillon. “Our heart team was fascinated with the ease of placement, the immediate performance of the therapy device and the rapid recovery of the very sick patients.”

The procedures were also attended and supported by William Cohn, M.D., director of Minimally Invasive Cardiac Surgery at the Texas Heart Institute in Houston, Texas, Eugene Grossi, director of Cardiac Research at New York University Medical Center in New York, N.Y., and Vivek Rao, M.D., chief of Cardiac Surgery at Toronto General Hospital in Canada.

“The VenTouch System is a promising technology that addresses both the annular and muscular abnormalities associated with FMR,” said Cohn. “I was extremely impressed with the marked reduction in regurgitation we were able to demonstrate after a quick, off-pump procedure through a small incision.”

FMR occurs when the left ventricle of the heart is enlarged and the mitral valve no longer closes properly. With each heartbeat, blood leaks backwards into lungs creating debilitating symptoms. If left untreated, FMR overloads the heart and can lead to or accelerate heart failure, a condition that affects 5.8 million people in the United States alone. The current treatment for FMR is repairing the mitral valve, an open-heart surgical procedure on bypass pump which can be difficult to perform and risky for sicker patients. Even after successful repair surgery, FMR can reoccur because the ventricle often continues to get larger.

“Having now successfully treated patients with the VenTouch System, Mardil has taken an an important step towards our goal of introducing this therapy and giving FMR patients a promising and significantly less invasive treatment option,” said Jim Buck, president and CEO of Mardil Medical.

The VenTouch System treats the root cause of FMR – the enlarged, injured left ventricular. The VenTouch System’s delivery tool deploys the VenTouch System’s therapy device through a small incision between the ribs and guides it over the beating heart. The therapy device is a biomaterial sleeve fitted with an inflatable, adjustable fluid chamber which applies prescriptive pressure to a targeted location in order to realign valve leaflets, stopping the leaking by improving the shape and reducing the stress of the enlarged heart. If any further changes in the left ventricle occur after implantation, the VenTouch can be adjusted using a remote port.

Mardil Medical, Inc., is headquartered in Minneapolis and develops implantable medical devices designed for treating structural heart disease and related conditions.