ARNHEM, Netherlands, November 1, 2023 — SINOMED today announced that its HT Supreme™ Drug-Eluting Stent System has received certification under the European Union Medical Device Regulation (EU MDR 2017/745). The certification was granted by DEKRA Certification B.V. (NB 0344), the Notified Body based in Arnhem, Netherlands. The HT Supreme™ is one of the first drug-eluting stents to be certified under the new MDR framework, marking SINOMED’s entry into the European market under the most stringent regulatory standards.
EU MDR 2017/745, which became fully applicable in May 2021, represents a significant tightening of European medical device regulations compared with the previous MDD framework. The HT Supreme™ certification under MDR reflects the device’s compliance with the highest standards of safety, clinical performance, and post-market surveillance.
The HT Supreme™ is a healing-targeted drug-eluting stent featuring a biodegradable polymer sirolimus-eluting platform, with complete drug elution within 30 days and full polymer degradation within 60 days. Its proprietary electro-grafting (eG™) coating serves as a bare-metal barrier that preserves coating integrity and promotes accelerated endothelialization, supporting safe DAPT de-escalation.
This certification provides SINOMED with access to the European Union market, the second-largest medical device market globally. Combined with its existing U.S. FDA-cleared balloon portfolio, the EU MDR certification enables SINOMED to offer a comprehensive interventional cardiology solution to physicians worldwide.
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.