Reshaping Technology Treats Mitral Valve Regurgitation

A novel investigational device treats the root cause of functional mitral valve regurgitation (FMR)—the enlarged, injured, left ventricle.

The VenTouch ventricular reshaping device is a biomaterial sleeve fitted with an inflatable, adjustable, fluid chamber that applies gentle, prescriptive pressure to a targeted location in order to realign valve leaflets, thus stopping the leaking valve. In addition, the system provides gentle support to the ventricular wall, helping to relax wall stresses and prevent further distortion, which can lead to reoccurrence of FMR. If any further changes in the left ventricle occur after implantation, the therapy device can be adjusted using a remote port. The implantation procedure does not involve open-heart surgery, cardiopulmonary bypass, or access to any blood vessels. 

Instead, the VenTouch device is slipped around the beating heart through a small incision between the ribs, helping to speed patient recovery, reduce surgical complications, and decrease surgical time. The first-in-human implants were performed in February 2014 at Institut Jantung Negara National Heart Institute (IJN; Kuala Lumpur, Malaysia), in two patients with severe FMR, which was reduced to only trace amounts after implantation. The VenTouch ventricular reshaping device is a product of Mardil Medical (Minneapolis, MN, USA), and is currently undergoing global clinical trials.

“After implantation of the VenTouch System’s 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 Jeswant Dillon, MD, clinical director of adult surgery at the IJN. “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.”

“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,” said Jim Buck, president and CEO of Mardil Medical.

FMR is considered a disease of the left ventricle, not of the mitral valve, and occurs when the left ventricle of the heart is distorted or enlarged, displacing the papillary muscles that support the two valve leaflets and stretching the annulus. The valve leaflets can no longer come together to close the annulus and blood flows back into the atrium. If left untreated, FMR overloads the heart and can lead to or accelerate heart failure.

Related Links:
IJN National Heart Institute 
Mardil Medical