Valtech Cardio Replaces Need for Open-Heart Surgery

Until recently, patients suffering from mitral regurgitation (MR), a condition in which heart valves fail to close properly, could only be treated by open-heart surgery, while many others, because of the high risks involved with open-heart surgery, could not be treated at all.

Or Yehuda-based Valtech Cardio Ltd., has developed a technology that repairs the malfunctioning valves without the need for open-heart surgery and that can be made available to a large number of patients that previously were untreatable.

A device the company has developed known as the Transfemoral Cardioband™ Annuloplasty System was successfully implanted during February and April this year in patients at the San Raffaele Hospital, Milan, Italy as part of a clinical trial. The patients were discharged 48-72 hours after the intervention.

“Being able to deliver the surgical gold standard solution, via a transfemoral approach is a major milestone,” stated Amir Gross, Founder and Chief Operating Officer of Valtech Cardio.

MR is the most common valve pathology in the US. Valve disease prevalence rises dramatically with age, reaching epidemic levels in the elderly. Over 6.8 million people suffer from the disease and each year 250,000 patients are diagnosed with MR. If untreated, MR can cause shortness of breath, decreased cardiac output, intolerance to physical exercise, congestive heart failure and death.

The standard-of-care in surgically treating MR involves placing an artificial ring around the mitral valve to stabilize the shape and size of the annulus.

Instead of implanting the annuloplasty ring via open heart surgery, which involves putting the patient on a cardiac bypass machine and stopping the heart, the Valtech Cardio device is inserted through a vein (artery?) in the lower part of the body.

Connection of the band to the mitral annulus is sutureless, using specially designed anchors. The implant is then adjusted, under beating heart conditions and echocardiographic guidance for optimal results. There is expected to be a high demand for the Valtech Cardio device as open heart surgery leaves many early and late-stage patients without a treatment alternative. Only 20% of the patients with mitral regurgitation that should be treated because of the severity of their disease currently undergo surgery.

A multi-center study is currently ongoing in leading European centers to study the safety and efficacy of the Transfemoral Cardioband Annuloplasty System.

Valtech’s first surgical device, the Cardinal adjustable annuloplasty ring, was approved for commercialization in the European Union in 2011. Over 75 patients have been implanted to date with the Cardinal ring.