The company initiated its U.S. Early Feasibility Study, following receipt of approval from the U.S. Food and Drug Administration (FDA), with the successful first two implantations of the TriCinch Coil System at Piedmont Heart Hospital, Atlanta, Georgia, by Dr. Christopher Meduri, Dr. Vivek Rajagopal and Dr. Mani Vannan.

The study will evaluate the TriCinch Coil System in 15 patients across seven centers in the US.

Christopher Meduri said: “We are pleased to be the first center in the US to implant the TriCinch Coil System. Both procedures went smoothly, and the device was easy to implant. Having a technology like the TriCinch Coil System in our structural heart toolkit allows us to treat a wide range of patients suffering from tricuspid regurgitation, who are at high risk for open heart surgery, in a safe and simple manner.”

The 4TECH TriCinch Coil System is a simple percutaneous direct annuloplasty device designed to reduce tricuspid regurgitation by means of tricuspid valve (TV) remodeling via a unique nitinol coil anchor that is tensioned by a nitinol stent in the inferior vena cava (IVC).

4TECH CEO Tom Fleming said: “This is a major milestone for 4TECH, and I am excited with the progress the team has made. The TriCinch Coil System is designed to simply target the underlying pathology of annular dilatation. With this device, we are committed to helping patients who have very limited treatment options.”

4TECH chief medical officer Keith D. Dawkins said: “Through our experience and in collaboration with key physicians, we have built a robust clinical program to evaluate the safety and efficacy of the device.

“I am encouraged by our momentum, and I am confident that we will provide physicians with a novel solution that will benefit patients suffering from TR.”

The device is being evaluated worldwide with a CE-Trial that has enrollment in both Australia and Europe.

About Tricuspid Regurgitation (TR)

Tricuspid regurgitation is a common condition that is age-related and difficult-to-manage, in which blood “backflows” into the right atrium. Today’s standard of care for TR is medical management. Surgical intervention is high-risk with an in-hospital mortality for isolated TR as high as 37%.

Patients with TR and related complications result in substantial healthcare spending due to frequent re-hospitalizations. Furthermore, TR leads to chronic renal failure and the need for end-stage dialysis. The combination of these negative outcomes results in a significant unmet need for a minimally invasive solution for TR.

Source: Company Press Release