Micro Interventional Devices has announced US Food & Drug Administration (FDA) investigational device exemption (IDE) approval for its MIA-T annuloplasty system for the treatment of tricuspid annular disease.
The approval will enable the commencement of a pivotal clinical trial—STTAR-US—of at several US hospitals.
The pivotal trial will assess annular treatment utilizing Micro Interventional Devices’ proprietary, polymeric PolyCor anchors developed specifically for use in cardiac tissue. The anchors are deployed into the tricuspid annulus via 12Fr delivery catheters. The technology is designed to treat functional tricuspid valve disease by reducing annular area, minimising tricuspid regurgitation (TR), and encouraging natural healing.
The STTAR-US steering committee is led by two principal investigators Bassem Chehab (University of Kansas, Wichita, USA) and Saibal Kar (Los Robles Regional Medical Center, Thousand Oaks, USA).
“This approval marks a critical milestone in the development of MIA-T. As one of the first percutaneous annular repair devices, we believe MIA-T will play a significant role in the emerging TTVr market,” said Michael Whitman, chief executive officer of Micro Interventional Devices.
