Mardil Medical Inc. has completed the first human implants of its new surgical therapy to reverse a heart disease called functional mitral valve regurgitation (FMR) that Mardil says affects nearly 6 million Americans.
Plymouth-based Mardil raised $6.1 million in 2012, mostly from a Malaysian venture fund to which it was introduced by Minnesota-based LifeScience Alley. Mardil says its VenTouch system is less invasive and more economical than open-heart surgery. A surgical team at National Heart Institute in Kuala Lumpur, Malaysia implanted the device in two patients who were very ill and part of a global clinical study.
"Our heart team was fascinated with the ease of placement, the immediate performance of the of the VenTouch and the rapid recovery of the [two] very sick patients," Dr. Jeswant Dillon, clinical director of adult surgery and chief cardiothoracic surgeon said in a statement. The procedure was also supported by leading surgeons from the Texas Heart Institute in Houston, New York University Langone Medical Center and Toronto General Hospital.
FMR occurs when the left ventricle of the heart is enlarged, the mitral valve no longer closes properly and the blood flows back into the atrium. Untreated, the FMR overloads the enlarging heart and can lead to accelerated heart failure and death. The current treatment requires open-heart surgery.
CEO Jim Buck, a veteran of St. Jude and smaller medical companies, said the successful treatment of "two very sick patients" with the Mardil's VenTouch system is a significant step toward eventual commercialization and widespread adaptation of "this groundbreaking therapy."
The VenTouch technology is rooted in intellectual property acquired largely from the former Acorn Cardiovascular and another development-stage company that ran out of money.
"Our approach is less invasive, less costly and directly addresses the underlying root cause of the condition in a safe fashion," Buck said.
The VenTouch system, purported to be the only device that treats the "root cause of FMR" is a "biomaterial sleeve fitted with an inflatable, adjustable fluid chamber that applies prescriptive pressure to a targeted location in order realign valve leaflets." In other words, it's designed to solve the problem and reshape the enlarged heart. The sleeve subsequently can be adjusted through a "port" just under the skin.