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This product is composed of a drug-eluting stent and a delivery system. The stent consists of three parts: the stent body, radiopaque markers, and a drug coating. The stent body material is poly-L-lactic acid (PLLA), with one radiopaque marker at each end of the stent. The sirolimus drug coating is sprayed on the outer surface of the stent unilaterally. The delivery system is a rapid exchange balloon dilatation catheter. This product is sterilized by irradiation, for single use, to improve the coronary lumen diameter and is suitable for patients with ischemic heart disease caused by native coronary artery lesions.
This product adopts a single-sided drug-coating technology, applying the drug only to the outer surface of the stent through a spot-coating process. The sides and inner surface of the stent struts are free of drug coating, which improves drug utilization and facilitates the vascular endothelialization process.
Source: Shanghai Medical Products Administration

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