US-based medical device firm Mitralign has started enrolling patients in the SCOUT study, which is designed to evaluate the company’s Trialign percutaneous tricuspid valve annuloplasty system (PTVAS).
In August, the company secured investigational device exemption (IDE) approval from US Food and Drug Administration (FDA) to conduct an early feasibility study to examine its PTVAS in patients with symptomatic chronic functional tricuspid regurgitation (FTR).
SCOUT is an early feasibility IDE study, which will evaluate the safety and feasibility of the device to treat 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 occurs when the tricuspid valve is unable to open and close properly, thereby causing the blood to flow backwards into the right atrium.
The company noted that FTR 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 US, yet little progress has been made developing tricuspid specific therapies."
It is estimated that 50% of patients with mitral regurgitation have moderate to severe tricuspid regurgitation. In the US, surgeons treat only 5,500 patients per annum, most of them in conjunction with left heart surgeries.