China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approvals for two of its medical devices in Hong Kong, China, and Malaysia. The NC Rockstar non compliant coronary artery balloon dilation catheter has been approved in Hong Kong and China, while the HT Supreme drug eluting stent system has been approved in Malaysia.
The NC Rockstar catheter is designed for balloon dilation of autologous coronary artery or bypass stenosis to improve myocardial perfusion in atherosclerotic patients and is also suitable for post-delivery expansion of balloon expandable stents, including bare metal and drug eluting stents. This product has previously obtained marketing approval in China mainland, the United States, Thailand, and Taiwan, China.
The HT Supreme drug-coated coronary stent system, a drug-device combination product, consists of a drug-coated expandable cobalt chromium (CoCr) alloy coronary stent and a balloon delivery system. It is indicated for improving the coronary artery lumen diameter in symptomatic heart disease patients with primary coronary artery lesions (length ≤ 35 mm) and a reference vessel diameter of 2.50-4.00 mm. The product is also registered in Thailand, Singapore, Indonesia, Turkey, Taiwan, and the European Union. It was included in the continuous national volume-based procurement (VBP) of coronary stents in China following the agreement expiration in December 2022.- Flcube.com
