China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received Medical Device Regulation (MDR) approval in the European Union for its HT Supreme drug-eluting stent system.
Features of the HT Supreme Drug-Coated Coronary Artery Stent System
The HT Supreme drug-coated coronary artery stent system is a combination drug-device product. It comprises a drug-coated expandable cobalt chromium (CoCr) alloy coronary artery stent and a balloon delivery system. The stent’s scaffold is bottomed with a non-corrosive polymer layer, and its surface is coated with a biodegradable polymer layer designed for drug release. The biodegradable polymer layer releases a mixture of sirolimus and biodegradable polymers. The product utilizes a rapid exchange balloon expandable conveying system to deploy the stent. In addition to EU MDR approval, the product is also registered in Thailand, Singapore, Indonesia, Turkey, and Taiwan.- Flcube.com
