4Tech's Transcatheter Tricuspid Valve Repair System Used Without TEE or General Anesthesia in Feasibility Study

September 27, 2016—4Tech Inc., which is developing the TriCinch transcatheter device for tricuspid heart valve repair, recently announced that the device has been used in the first-ever successful transcatheter tricuspid valve repair without the use of transesophageal echocardiography (TEE) or general anesthesia to successfully treat a patient with tricuspid regurgitation (TR). The procedure, which was performed in < 1 hour at San Raffaele Hospital in Milan, Italy, achieved substantial TR reduction.

According to 4Tech, the ongoing feasibility study is being conducted at San Raffaele Hospital and other sites in Italy and in Europe. The TriCinch feasibility study investigators at San Raffaele Hospital include Senior Interventional Cardiologist, Azeem Latib, MD; Senior Echocardiographer, Eustachio Agricola, MD; and hybrid cardiovascular surgeon, Paolo Denti, MD.

In the company’s announcement, Dr. Agricola commented, “Our patient was at very high risk for surgical treatment, and she was referred to us by a cardiac surgeon. Equally critical, she was unable to undergo TEE because of an esophageal diverticulum, and thus there were extremely limited options for offering her any treatment.” He continued, “Given this patient was end-stage and had no other option, we are very proud of our physicians and staff at San Raffaele Hospital, who were able to perform an innovative percutaneous approach to treating tricuspid valve disease under local anesthesia.”

Dr. Latib added, “Fortunately, the extensive experience of the San Raffaele team with transcatheter treatment of the tricuspid valve and cardiac imaging allowed for the treatment. The successful treatment of this case opens up new options for minimally invasive treatment of patients with functional TR.”

The TriCinch system for transcatheter tricuspid valve repair is designed to reduce TR and restore patient quality of life, as well as potentially to provide substantial cost savings for health care systems. The TriCinch system is in the early phase of development and is not yet available in the United States for clinical trials. The device is not available for sale, advised 4Tech.