Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received market approval from the Taiwan Food and Drug Administration (TFDA) for its HT Supreme drug-eluting stent system. This significant milestone marks the company’s expansion into the Taiwan market with a cutting-edge drug-device combination product.
HT Supreme Drug-Coated Coronary Artery Stent System
The HT Supreme system is a sophisticated drug-device combination, comprising a drug-coated expandable cobalt chromium (CoCr) alloy coronary artery stent and a balloon delivery system. The stent’s design includes a non-corrosive polymer layer at the scaffold’s base and a biodegradable polymer layer on the surface for drug release. The drug release mechanism involves a mixture of sirolimus and biodegradable polymers, which are delivered using a rapid exchange balloon expandable conveying system.
Innovative Design and Development Theory
The HT Supreme product is developed based on Sino Med’s proprietary “Healing window stage” theory, which focuses on optimizing the healing process post-implantation. This innovative approach aims to enhance the safety and efficacy of the stent system, providing a superior option for patients undergoing coronary artery stenting procedures.-Fineline Info & Tech
