Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical technology company, has announced that it has received marketing approval in Peru for its HT Supreme drug-eluting stent system. This approval allows the use of the system to improve the diameter of the coronary artery lumen in symptomatic heart disease patients with primary coronary artery lesions of length ≤ 40 millimeters and a reference vessel diameter of 2.25~5.00 millimeters.
HT Supreme Stent System Description
The HT Supreme drug-coated coronary artery stent system is a drug-device combination product that comprises a drug-coated expandable cobalt chromium (CoCr) alloy coronary artery stent and a balloon delivery system. The stent’s scaffold is coated with a non-corrosive polymer layer at the bottom and a biodegradable polymer layer on the surface for drug release. The biodegradable polymer layer contains a mixture of sirolimus and biodegradable polymers, utilizing a rapid exchange balloon expandable conveying system to transport the stent.
Regulatory Approvals and Market Expansion
The product was approved for marketing in China in December 2020 and won a bid in the continuing procurement of coronary stents involved in the national volume-based procurement (VBP) upon agreement expiry two years later. In addition to Peru, HT Supreme is registered in several countries, including Thailand, Singapore, Indonesia, Türkiye, Taiwan, Malaysia, India, Bangladesh, Hong Kong, South Korea, Belarus, Mexico, and Morocco, and holds a CE mark in the European Union (EU). The company is awaiting regulatory decisions in the US, which would further expand its global market reach.-Fineline Info & Tech
Leave a Reply