Mitralign has announced that enrolment in the first phrase of its SCOUT study, which is evaluating percutaneous tricuspid repair with the Trialign system in patients with functional tricuspid regurgitation, has been completed. The company has also revealed that it has recently received approval to expand the study and enrol an additional cohort of patients in the USA.
Principal investigator of SCOUT, Rebecca Hahn (New York-Presbyterian/Columbia University Medical Center, USA), comments: “The clinical community is excited about the potential opportunity to provide a breakthrough non-surgical option for patients with tricuspid regurgitation. We know the number of people suffering with tricuspid regurgitation is much bigger than previously reported, and we are in the nascent stages of treating this large, unaddressed population. The Trialign System leaves behind a very small footprint, so we believe this device has the potential to be a front line solution for patients with functional tricuspid regurgitation.”
According to Rick Geoffrion, chief executive officer of Mitralign, the completion of enrolment for this initial group of 15 patients “is a significant milestone for the company and the industry”. He adds: “This is the first US early feasibility study to complete enrolment using a transcatheter device to treat the tricuspid valve. The SCOUT study marks initiation of the path to evaluate catheter-based tricuspid repair for patients suffering from tricuspid regurgitation. We are pleased to announce we have also recently received approval to expand the study and enrol an additional cohort of patients in the USA.”