The ventouch™ targeted ventricular reshaping system

Targeting FMR’s root cause mechanism

The VenTouch™ System is the only therapy that targets the root cause mechanism of FMR (Functional Mitral Valve Regurgitation) by applying light pressure to push the valve leaflets closer together, stopping the regurgitation. In addition, the VenTouch System provides gentle support to the ventricular wall, helping to relax wall stresses and prevent further distortion which can lead to reoccurrence of FMR.

A simple, minimally invasive procedure

The VenTouch device is implanted without open-heart surgery, cardiopulmonary bypass or stopping the heart, unlike current surgical procedures. The implantation procedure does not require access to any blood vessels or leave anything inside the heart. 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. If any further changes in the left ventricle occur after implantation, the VenTouch System is the only therapy that can be adjusted using a remote port after implantation to reduce FMR.

Years of careful study

The design of the VenTouch System is the result of leveraging knowledge and technology gained after years of careful scrutiny of the successes and failures of other relevant device therapies focused on the treatment of FMR and heart failure. Small, encouraging human clinical trials have been conducted with Mardil first-generation devices uniquely created for demonstrating feasibility for the concept of ventricular reshaping to treat FMR. The VenTouch System was designed to provide an optimized safety, effectiveness and cost efficiency in pursuit of global commercial acceptance. A multi-center clinical trial is underway in leading Canadian and European medical centers. For more information about the study, please contact us (see sidebar at right).

The company estimates the annual market potential for the VenTouch System to be $1.4 billion in the U.S. alone, $2.6 billion worldwide.

Caution: Investigational device limited by Federal (USA) Law to investigational use

fmr overview

a disease of the left ventricle

Functional mitral valve regurgitation (FMR) is considered a disease of the left ventricle, NOT of the mitral valve. FMR occurs when the left ventricle of the heart is distorted or dilated (enlarged), displacing the papillary muscles that support the two valve leaflets and stretching the valve opening (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, a debilitating condition that affects 5.8 million people in the U.S. at a cost of $39.2 billion in 2010.¹

current surgical treatment

Rather than replacing the diseased valve, surgeons favor repairing the valve with a procedure called Annuloplasty for over thirty years. This involves the implantation of a ring or band in the annulus to restore its normal shape. The surgical technique and annuloplasty ring design has not changed significantly over the last decade.

Annuloplasty is challenging to perform and very invasive (open-heart and on bypass), and because the cause of the FMR is not addressed (left ventricular distortion or dilation), regurgitation may reoccur in 40% or more of patients.² Since the surgical risks are significant and there is a high rate of reoccurrence, only a small fraction of indicated patients undergo surgical procedures for FMR every year.³

1. American Heart Association. Heart Disease and Stroke Statistics – 2010 Update. Dallas, Texas: American Heart Association; 2010.

2. The Journal of Thoracic and Cardiovascular Surgery, 2004;128:916-924. Read this paper >

3. Dymedex Consulting, Market Opportunity Assessment performed for Mardil Medical, May 2011. >