Sino Medical Sciences Technology Inc. (SHA: 688108), based in China, has announced the five-year follow-up results from the Phase III PIONEER study for its first-in-class HT Supreme drug-eluting stent system across the United States, Japan, and Europe.
The HT Supreme system represents a significant milestone as the first cardiac stent product independently developed by a Chinese manufacturer to undergo concurrent pre-market studies in the U.S., Japan, and Europe, with marketing applications filed in these regions. Approved for use in China in December 2020, the stent subsequently won a bid in the national volume-based procurement (VBP) process as its agreement ended two years later. The product is also registered in multiple international markets, including Thailand, Singapore, Indonesia, Turkey, Taiwan, Malaysia, India, Bangladesh, Hong Kong, South Korea, Belarus, Mexico, and Morocco, and holds a CE mark in the EU, with pending regulatory decisions in the U.S.
The PIONEER study series (I-IV), initiated by Sino Medical, marks the first set of pre-marketing clinical trials for stents conducted by a Chinese cardiovascular device company, covering regions such as China, the U.S., Europe, and Japan. Results indicate that while there was no statistically significant difference in overall target lesion failure rates, target vessel failure rates, major adverse cardiac event rates, or stent thrombosis rates between the HT Supreme trial group and the control group over the 2-5 year period, the HT Supreme stent exhibited numerical advantages in all measured safety and efficacy parameters.- Flcube.com
