Medical device firm Mitralign has enrolled first patient in the SCOUT study, which will evaluate the firm’s Trialign (percutaneous tricuspid valve annuloplasty) system.
The company received FDA IDE approval in August to carry out early feasibility study of Trialign system to treat patients with symptomatic chronic functional tricuspid regurgitation (FTR).
The trial will evaluate the early safety and feasibility of the device for the treatment of tricuspid regurgitation in subjects with a minimum of moderate tricuspid regurgitation and in whom left-sided valve surgery is not planned.
SCOUT study principal investigator Dr Rebecca Hahn said: "We are extremely excited to be pioneering a novel solution in percutaneous repair for the tricuspid valve.
"Given the reports that operative mortality for tricuspid valve replacement (TVR) surgery can top 30%, coupled with the lack of treatment options, this system represents a very welcome advancement."
FTR or tricuspid insufficiency takes place when the tricuspid valve is unable to open and close properly, thereby causing the blood to flow backwards into the right atrium.
It is likely to cause heart enlargement and heart failure, if left untreated.
Mitralign CEO Rick Geoffrion said: "An estimated 1.6 million patients suffer from tricuspid regurgitation in the U.S.2, yet little progress has been made developing tricuspid specific therapies."