4TECH has initiated its US early feasibility study, following receipt of approval from the US FDA, with the successful first two implantations of the TriCinch Coil system at Piedmont Heart Hospital, Atlanta, Georgia, by Christopher Meduri, Vivek Rajagopal and Mani Vannan. The study will evaluate the TriCinch Coil System in 15 patients across seven centres in the USA.
A press release reports that the 4TECH TriCinch Coil System is a simple percutaneous direct annuloplasty device designed to reduce tricuspid regurgitation by means of tricuspid valve remodelling via a nitinol coil anchor that is tensioned by a nitinol stent in the inferior vena cava.
Meduri comments: “We are pleased to be the first centre in the USA 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.”
Keith D Dawkins, 4TECH chief medical officer, says: “Through our experience and in collaboration with key physicians, we have built a robust clinical programme 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 tricuspid regurgitation.”
The device is being evaluated worldwide with a CE-Trial that has enrolment in both Australia and Europe.