SILVER SPRING, Maryland, USA, August 7, 2025 — SINOMED today announced that its controlled subsidiary SINOMED Neurovita Technology Inc’s COMETIU™ self-expanding intracranial drug-coated stent system and COMEX™ balloon microcatheter have received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). COMETIU™ is the first product worldwide to receive FDA Breakthrough Device Designation for the treatment of intracranial atherosclerotic stenosis (ICAS), and the first Chinese neurointerventional device to receive this prestigious designation.
Based on the Breakthrough Device Designation, the FDA confirmed that COMETIU™ may bypass Early Feasibility Studies (EFS) and proceed directly to an IDE Pivotal Study in the United States to support PMA approval, significantly accelerating the U.S. regulatory pathway.
The COMETIU™ stent system is the world’s first self-expanding nickel-titanium alloy drug-coated stent specifically designed for intracranial atherosclerotic stenosis. Its structure comprises a bare nickel-titanium mesh stent, a base coating (PBuMA), and a sirolimus biodegradable polymer coating (PLGA). It is designed for reference vessel diameters of 2.0–4.5 mm and lesion lengths up to 34 mm, paired with the COMEX™ balloon microcatheter as a complete system solution.
This designation marks SINOMED’s second major U.S. regulatory milestone within one month, following the HT Supreme™’s conditional PMA approval in July 2025. Together, these achievements demonstrate the company’s growing presence in the U.S. interventional device market across both coronary and neurointerventional segments.
About SINOMED
SINOMED is a global medical device company engaged in research, development, production, and commercialization of interventional devices. We are focused on developing first-in-class technologies to target unmet clinical needs in the interventional treatment of coronary, neurovascular and structural heart disease. Our mission is to bring the benefits of medical innovation to more patients worldwide, improving both the longevity and quality of their lives.