4Tech said that it launched an FDA-approved U.S.-based early feasibility study of its TriCinch coil system intended to reduce tricuspid regurgitation,
The first two successful implantations of the device were performed at Atlanta’s Piedmont Heart Hospital by Dr. Christopher Meduri, Dr. Vivek Rajagopal and Dr. Mani Vannan, the Ireland-based company said.
“We are pleased to be the first center in the U.S. 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,” Dr. Meduri said in a prepared statement.
The TriCinch coil system is a percutaneous direct annuloplasty device designed to remodel the tricuspid valve through a nitinol coil anchor tensioned by a nitinol stent in the inferior vena cava.
The system is currently being evaluated in a CE Mark trial seeking clearance in the European Union, with enrollment in Australia and Europe.
“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,” CEO Tom Fleming said in a press release.
“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,” CMO Dr. Keith Dawkins said in a prepared statement.