Micro Interventional Devices (MID) has received approval from the U.S. Food and Drug Administration (FDA) to initiate a pivotal clinical trial for its innovative tricuspid valve repair technology. The Investigational Device Exemption (IDE) enables MID to commence the STTAR-US trial at major hospitals throughout the United States. This trial is poised to enhance treatment options for patients grappling with functional tricuspid valve disease, a condition affecting a significant number of individuals.
The FDA’s approval follows MID’s designation under the Breakthrough Technology Designation program, underscoring the device’s potential to address a serious cardiac condition that has long been underserved. The STTAR-US trial will focus on evaluating MID’s MIA-T system, which employs proprietary PolyCorTM anchors. These specialized polymeric implants are designed for cardiac tissue and are delivered through 12F catheters. The anchors aim to reduce the tricuspid annular area, mitigate tricuspid regurgitation (TR), and encourage natural tissue healing.
Leading Experts at the Helm of the Trial
The study will be led by principal investigators Dr. Bassem Chehab, an 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 physicians are well-regarded in the field of structural heart disease and will oversee a steering committee made up of leading cardiology experts.
In the United States, approximately 1.6 million people suffer from tricuspid regurgitation, yet only a small percentage qualify for existing surgical or transcatheter treatments. MID’s MIA-T technology aims to bridge this gap, providing a minimally invasive option for patients who are not suitable candidates for surgery or transcatheter edge-to-edge repair (TEER) procedures.
Significance of FDA Approval
“This approval marks a critical milestone in the development of MIA-T,” said Michael Whitman, Chief Executive Officer of Micro Interventional Devices. He emphasized that MIA-T is among the first percutaneous annular repair devices, which could have a substantial impact on the evolving market for tricuspid valve repair (TTVr). The global market for such technologies is projected to exceed $3 billion annually by 2027, with expected rapid growth as minimally invasive options become more prevalent.
Whitman expressed confidence in the potential of the MIA-T system to deliver meaningful patient outcomes and significant value for stakeholders, noting that there is currently no established percutaneous standard of care for treating tricuspid regurgitation. With the FDA’s endorsement, MID is ready to begin enrolling patients and collecting pivotal data that could redefine non-surgical cardiac repair options.
As this trial unfolds, the healthcare community will closely monitor its progress, which could play a crucial role in expanding treatment avenues for patients with limited options.
