MID’s MIA-T Tricuspid Annuloplasty System Receives IDE Approval for Pivotal Trial

October 20, 2025—Micro Interventional Devices (MID) announced that the FDA has approved an investigational device exemption (IDE) for its MIA-T minimally invasive annuloplasty–tricuspid technology to be used for the treatment of tricuspid annular disease in the STTAR-US pivotal clinical trial.

MID advised it has been working closely with the FDA after receiving Breakthrough Device designation for the MIA-T in May 2021.

According to the company, the STTAR-US trial will evaluate an annular treatment utilizing MID’s polymeric PolyCor anchors, which were developed specifically for use in cardiac tissue. These anchors are deployed into the tricuspid annulus via 12-F delivery catheters. The technology is designed to treat functional tricuspid valve disease by reducing annular area, minimizing tricuspid regurgitation, and encouraging natural healing, noted MID.

As stated in the press release, the STTAR-US trial will be led by Principal Investigators Bassem Chehab, MD, and Saibal Kar, MD.

Dr. Chehab is Associate Professor of Medicine at the University of Kansas and Director of Structural Cardiology, Clinical Cardiology and Research at Ascension Health in Wichita, Kansas. Dr. Kar is Program Director, Cardiovascular Disease Fellowship, at Los Robles Regional Medical Center in Thousand Oaks, California and the National Physician Director, Interventional Cardiology HCA Healthcare US.