SILVER SPRING, Maryland, USA, July 22, 2025 — SINOMED today announced that its flagship HT Supreme™ Drug-Eluting Stent System has received conditional Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA). HT Supreme™ is the first China-originated Class III implantable medical device to obtain FDA PMA approval, marking a historic milestone for SINOMED and the broader Chinese interventional cardiology industry.
The PMA application journey for HT Supreme™ spanned over four years: the final PMA submission was filed with the FDA on December 3, 2021; an FDA on-site inspection in August 2023 was completed with VAI (Voluntary Action Indicated) classification; a pre-approval on-site audit was conducted from March 24–31, 2025; and conditional approval was granted on July 21, 2025.
According to the company announcement, “The conditional FDA approval of our new-generation drug-eluting stent system represents an important milestone in the coronary field, signifying that our stent product has met the U.S. FDA’s technical review standards. We still need to complete the relevant targeted improvements required by the FDA before obtaining the formal approval letter and commencing commercial sales in the United States.”
The HT Supreme™ features a biodegradable polymer sirolimus-eluting platform combined with a proprietary electro-grafting (eG™) coating that serves as a bare-metal barrier. This design supports accelerated endothelialization, complete drug elution within 30 days, and full polymer degradation within 60 days, enabling safe DAPT de-escalation—a critical benefit for high-bleeding-risk patients.
With this approval, HT Supreme™ becomes commercially available in the United States (pending formal approval completion), the European Union, and over 30 other markets worldwide, establishing SINOMED as a global competitor in the drug-eluting stent market.
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.