US-based Mardil Medical has completed the first human implants of its VenTouch ventricular reshaping device, a new treatment option for functional mitral valve regurgitation (FMR), at the Institut Jantung Negara (IJN) National Heart Institute in Kuala Lumpur, Malaysia.
Dr Jeswant Dillon, clinical director of adult surgery and Dr Mohd Azhari Yakub, chief cardiothoracic surgeon, have implanted the device as part of a multi-centre, global clinical study in two patients with severe FMR, which was reduced to only trace amounts after implantation.
The first patient presented several challenges due to severe FMR combined with significant heart dilation and poor left ventricular function.
FMR occurs when the left ventricle of the heart is enlarged and the mitral valve no longer closes properly.
Dr Dillon said 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.
"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," Dr Dillon said.
The procedures were also attended and supported by Dr William Cohn, director of minimally invasive cardiac surgery at the Texas Heart Institute in Houston, Dr Eugene Grossi, director of cardiac research at New York University Medical Center and Dr Vivek Rao, chief of cardiac surgery at Toronto General Hospital.
"The VenTouch System is a promising technology that addresses both the annular and muscular abnormalities associated with FMR," Dr Cohn said.
"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."
Unlike current surgical procedures, the VenTouch device is implanted without open-heart surgery, cardiopulmonary bypass or stopping the heart.
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.
Its makers claim it is the only device that treats the root cause of FMR. It features a biomaterial sleeve fitted with an inflatable, adjustable fluid chamber that applies prescriptive pressure to a targeted location in order to realign valve leaflets.
The device helps stop leaking by improving the shape and reducing the stress of an enlarged heart.
If any further changes in the left ventricle occur after implantation, the VenTouch system can be adjusted using a remote port after implantation.
Mardil Medical president and CEO Jim Buck said: "Having now successfully treated patients with the VenTouch System, Mardil has taken an important step towards our goal of introducing this ground-breaking therapy and giving FMR patients a promising and significantly less invasive treatment option."
The VenTouch System is relatively easier to perform, is less invasive, lowers risk and helps in speedy recovery compared with repairing of the mitral valve, the current treatment for FMR.