NEWTOWN, PA — Micro Interventional Devices (MID) announced that the U.S. Food and Drug Administration (FDA) has granted approval for an Investigational Device Exemption (IDE), allowing the company to begin its pivotal STTAR-US clinical trial at major hospitals across the United States. The trial marks a significant step forward in advancing treatment options for patients suffering from functional tricuspid valve disease.
The approval follows MID’s earlier recognition under the FDA’s Breakthrough Technology Designation program, reflecting the device’s potential to address a serious and underserved cardiac condition.
The STTAR-US trial will evaluate MID’s MIA-T system, which uses proprietary PolyCor™ anchors—polymeric implants engineered specifically for cardiac tissue. Delivered via 12F catheters, these anchors are designed to reduce the tricuspid annular area, minimize tricuspid regurgitation (TR), and promote natural tissue healing.
Leading the study as principal investigators are Dr. Bassem Chehab, Associate Professor of Medicine at the University of Kansas and Director of Structural Cardiology at Ascension Health in Wichita, and Dr. Saibal Kar, Program Director of the Cardiovascular Disease Fellowship at Los Robles Regional Medical Center and National Physician Director of Interventional Cardiology at HCA Healthcare. Both are recognized experts in structural heart disease and will guide a steering committee composed of top cardiology thought leaders.
An estimated 1.6 million Americans suffer from tricuspid regurgitation, yet only a small fraction qualify for existing surgical or transcatheter treatments. MID’s technology aims to fill that gap by providing a minimally invasive alternative for patients deemed ineligible for surgery or transcatheter edge-to-edge repair (TEER) procedures.
“This approval marks a critical milestone in the development of MIA-T,” said Michael Whitman, Chief Executive Officer of Micro Interventional Devices. “As one of the first percutaneous annular repair devices, we believe MIA-T will play a significant role in the emerging TTVr market. The global market is projected to exceed $3 billion annually by 2027, with rapid growth expected as minimally invasive options advance and adoption increases.”
“With a rapidly growing global market and no established percutaneous standard of care for treating tricuspid regurgitation, we believe MIA-T has the potential to deliver both meaningful patient outcomes and significant value for our stakeholders,” he added.
With the FDA’s green light, MID is positioned to begin enrolling patients and generating pivotal data that could shape the future of non-surgical cardiac repair options.
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