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Mitralign obtains US FDA approval for SCOUT study of Percutaneous Tricuspid Valve Annuloplasty System

Medical innovation firm Mitralign has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to carry out early feasibility study to evaluate its Percutaneous Tricuspid Valve Annuloplasty System (PTVAS).

The company will conduct the SCOUT study at select centers in the US.

Tricuspid regurgitation (TR) occurs when the tricuspid valve is unable to open and close properly, thereby causing the blood to flow backwards into the right atrium. TR may cause heart enlargement and heart failure if it is untreated.

Mitralign CEO Rick Geoffrion said: "Percutaneous repair of the tricuspid valve represents one of the largest remaining unmet needs in the structural heart space."

SCOUT study principal investigator Dr Rebecca Hahn said: "Even though the first group of patients treated were very sick, compassionate use candidates in Europe, the system has shown an excellent safety profile along with tremendous improvements in significant clinical measures."

The firm is expected to obtain CE mark approval for Mitralign Percutaneous Mitral Repair System to treat functional mitral regurgitation (FMR) this year.

Both the systems, which are under clinical investigation, will not be available for sale or distribution.