ARNHEM, Netherlands, May 21, 2026 – SINOMED today announced that the Instructions for Use (IFU) for its HT Supreme® drug-eluting stent have been expanded to include a one-month Dual Antiplatelet Therapy (DAPT) regimen for all-comer patients, covering both Acute Coronary Syndrome (ACS) and Chronic Coronary Syndrome (CCS). The approval was granted by DEKRA Certification B.V. (NB 0344), the Notified Body based in Arnhem, Netherlands.
This regulatory milestone is underpinned by robust clinical evidence. The PIONEER IV EU trial demonstrated the safety and efficacy of the one-month DAPT strategy at one year in an all-comer population. The PIONEER III Global IDE trial reported a 0% one-year late thrombosis rate in complex lesion populations and numerically favorable five-year cardiovascular outcomes, including Target Lesion Failure (TLF), Target Vessel Failure (TVF), and Major Adverse Cardiac Events (MACE) when compared to contemporary controls such as XIENCE and Promus. To date, over 5,000 patients have been enrolled across pivotal trials conducted in North America, Europe, Japan, and China.
The scientific foundation for this expansion lies in the unique design of the HT Supreme®. It is a biodegradable polymer sirolimus-eluting stent engineered for rapid and complete drug elution, with sirolimus release completing within 30 days and full polymer degradation within 60 days. A proprietary electro-grafting (eGTM) coating acts as a bare-metal barrier, ensuring coating integrity and facilitating accelerated endothelialization. This distinctive combination supports early and complete vessel healing, providing the biological foundation necessary for safe DAPT de-escalation, particularly for patients at high bleeding risk.
The expanded indication further strengthens SINOMED’s global footprint. The HT Supreme® is commercially available across more than 30 countries worldwide. The device also received U.S. FDA Premarket Approval (PMA) conditional approval in 2025, marking a significant step in addressing unmet clinical needs in interventional cardiology.
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