Mitralign Commences Early Feasibility Study for Trialign System for Tricuspid Valve Repair

December 3, 2015—Mitralign Inc. announced that the first patient in the United States has been enrolled in the SCOUT early feasibility study using the company’s Trialign system for percutaneous tricuspid valve annuloplasty. The principal investigator of the SCOUT study, Rebecca Hahn, MD, and Susheel Kodali, MD, performed the procedure. Dr. Hahn is Director of Interventional Echocardiography, and Dr. Kodali is Director of the Structural Heart and Valve Program at New York-Presbyterian/Columbia University Medical Center in New York, New York.

SCOUT, which is studying the Trialign system in patients with symptomatic chronic functional tricuspid regurgitation, is being conducted in the United States under an investigational device exemption from the US Food and Drug Administration. The trial will assess the early safety and feasibility of the device for the treatment of tricuspid regurgitation in patients with a minimum of moderate tricuspid regurgitation and in whom left‐sided valve surgery is not planned.

In Mitralign’s press release, Dr. Hahn commented, “We are extremely excited to be pioneering a novel solution in percutaneous repair for the tricuspcid valve. Given the reports that operative mortality for tricuspid valve replacement surgery can top 30%, coupled with the lack of treatment options, this system represents a very welcome advancement.” The system is not available for commercial use, advised the company.