Ascension Health

FDA Approves Pivotal Trial for Novel Tricuspid Valve Repair Device MIA-T

- The FDA has approved Micro Interventional Devices' MIA-T system for pivotal clinical trial use, marking a significant milestone for percutaneous tricuspid valve repair technology. - The STTAR-US trial will evaluate MIA-T's proprietary PolyCor anchors that reduce annular area and minimize tricuspid regurgitation through 12F delivery catheters. - The device addresses a major unmet need, as 1.6 million Americans suffer from tricuspid regurgitation but only a small percentage are eligible for surgical treatment. - MIA-T is positioned to capture part of the rapidly growing transcatheter tricuspid valve repair market, projected to exceed $3 billion annually by 2027.