Feasibility Study Evaluates 4Tech's TriCinch Transcatheter Tricuspid Valve Repair

June 20, 2016—4Tech Inc. announced that the company’s transcatheter TriCinch device for repair of the tricuspid heart valve has been used to successfully treat patients with tricuspid regurgitation in an ongoing feasibility study that is being conducted at San Raffaele Hospital in Milan, Italy, and at other sites in Italy and Europe.

Prof. Ottavio Alfieri, MD, a cardiac surgeon and Head of the Cardiology Department at San Raffaele Hospital, stated, “Considering that these patients were all end stage with no other options, we are extremely proud of our physicians and staff at San Raffaele Hospital who are helping to pioneer an innovative percutaneous approach to treating tricuspid valve disease.”

According to the company, the TriCinch system allows a simple and reproducible percutaneous procedure, designed not only to reduce tricuspid regurgitation and restore patient quality of life, but to also allow substantial potential cost savings for health care systems. The 4Tech TriCinch system for transcatheter tricuspid valve repair is in the early phase of development. In the United States, the device will not be available for clinical trials until further notice and is not available for sale.

The 4Tech TriCinch device was invented by Prof. Francesco Maisano, MD, who was a senior surgeon at San Raffaele Hospital before being appointed as Chief of Cardiac Surgery at University Hospital in Zurich, Switzerland.

San Raffaele Hospital is a key center in Europe for the treatment of coronary artery diseases and structural heart diseases. In addition to Prof. Alfieri, who heads the Cardiology Unit at San Raffaele, Antonio Colombo, MD, heads the Interventional Cardiology Unit at the hospital. Dr. Colombo is also a visiting professor of medicine at Columbia University Medical Center in New York, New York. The investigators for the TriCinch feasibility study at San Raffaele Hospital include senior interventional cardiologist Azeem Latib, MD, and hybrid cardiovascular surgeon Paolo Denti, MD.

In the company’s announcement, Dr. Latib commented, “We are enthusiastic about the growing trend toward transcatheter treatment of all heart valve disease. From my clinical experiences to date, it appears that TriCinch has a chance to refashion the way in which Tricuspid heart valve disease is treated in the future, and we look forward to continuing our efforts to develop and validate the technology in more patients.”

Dr. Denti added, “We must not forget that the patients who are benefitting from the TriCinch approach to treating tricuspid regurgitation had no other option left to them.”