4Tech Device Used in World’s First Transcatheter Tricuspid Valve Repair Without Anesthesia

4Tech Inc., which is developing the world’s first transcatheter device, TriCinch for repair of the tricuspid heart valve, announced that its device has been used in the world’s first-ever successful transcatheter tricuspid valve repair without use of transesophageal echocardiography (TEE) or general anesthesia. The device was used to successfully treat a patient suffering from tricuspid regurgitation (TR), which afflicts more than 3 million patients in the United States and Europe, making the potential TR patient population approximately two-thirds the size of the MR (mitral regurgitation) patient population. The TriCinch implant took less than one hour and allowed substantial reduction of TR.

Watch the video below to learn more about TriCinch:

 

The ongoing feasibility study is being conducted at San Raffaele Hospital and in other sites in Italy and in Europe. The Cardiology Unit at San Raffaele Hospital is headed by Professor Ottavio Alfieri and is a leading institution for heart valve studies. The Interventional Cardiology Unit at San Raffaele Hospital is directed by Dr. Antonio Colombo and is a key center in Europe for treatment of coronary artery diseases and structural heart diseases. Colombo is also a visiting professor of medicine at Columbia University Medical Center in New York, N.Y. The investigators for the TriCinch feasibility study at San Raffaele Hospital include Dr. Azeem Latib, senior interventional cardiologist; Dr. Eustachio Agricola, senior echocardiographist; and Dr. Paolo Denti, hybrid cardiovascular surgeon.
 
“Our patient was at very high risk for surgical treatment, and she was referred to us by a cardiac surgeon,” said Agricola. “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.”
 
“Fortunately, the extensive experience of the San Raffaele team with transcatheter treatment of the tricuspid valve and cardiac imaging allowed for the treatment,” added Latib. “The successful treatment of this case opens up new options for minimally invasive treatment of patients with FTR (Functional Tricuspid Regurgitation).”
 
TR is a difficult-to-manage, age-related disease in which blood “backflows” into the right side of the heart. Today’s standard of care for TR is medical management. Surgical intervention is very high-risk. In-hospital death post-cardiac surgery for isolated TR can be as high as 37 percent (Source: McCarthy et al. Journal of Thoracic and Cardiovascular Surgery, 2004). Unfortunately, TR patients tend to be non-compliant with their medications. Thus, TR and related complications induce substantial healthcare spending due to frequent re-hospitalizations. Furthermore, TR leads to chronic renal failure and end-stage dialysis. The combination of these negative outcomes results in a significant unmet need for an interventional cardiology solution to TR.
 
4Tech Inc. is incorporated in Delaware, with operations in Galway, Ireland (4Tech Cardio Ltd). 4Tech has developed a proprietary transcatheter solution for the treatment of TR. Because of its anchoring and tensioning mechanism, the 4Tech TriCinch System for Transcatheter Tricuspid Valve Repair (TTVR) allows a simple and reproducible percutaneous procedure, designed not only to reduce TR and restore patient quality of life, but also allow substantial potential cost-savings for healthcare systems.