Recently, the innovative product "Bioresorbable Rapamycin Target Eluting Coronary Scaffold System" of Shanghai MicroPort Medical (Group) Co., Ltd. is approved by China NMPA.

This product consists of a drug-eluting stent and a delivery system. The stent consists of three parts: the stent body, radiopaque markers, and drug coating. The stent body is made of poly-L-lactic acid (PLLA), with one radiopaque marker at each of the proximal and distal ends of the stent. The rapamycin drug coating is sprayed onto a single side of the outer surface of the stent. The delivery system is a rapid exchange balloon dilatation catheter. This product is sterilized by irradiation and is intended for single use. It is designed to improve the luminal diameter of the coronary artery and is indicated for patients with ischemic heart disease due to primary coronary artery lesions.

The product utilizes a single-sided drug coating technology, where the drug is applied only to the outer surface of the stent through a spot-coating process. This design ensures that the sides and inner surface of the stent struts are free of drug coating, thereby enhancing drug utilization and promoting the endothelialization process within the vessel.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.