The FDA has granted Mitralign investigational device exemption approval for the company to conduct an early feasibility study to examine its percutaneous tricuspid valve annuloplasty system. The SCOUT Study will take place in select centres in the USA. A press release reports that the percutaneous tricuspid valve annuloplasty system uses the same “innovative platform” as Mitralign’s percutaneous mitral repair system.
According to the press release, both systems are under clinical investigation and not available for sale or distribution. However, it adds that the percutaneous mitral repair system expected to receive CE mark approval for treatment of functional mitral regurgitation this year.
Rebecca Hahn (director of Interventional Echocardiography, Columbia University Medical Center / New York Medical Center / New York Presbyterian Hospital), principal investigator for the SCOUT study, states: “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. This patient population has very limited options, and the possibility of performing a transcatheter repair is very exciting. This innovation has significant potential to be a first line therapy.”