China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received market approval for its drug-eluting stent system. The system is designed to improve the symptoms of vascular stenosis in patients with ischemic heart disease, with a reference blood vessel diameter of 2.25-4 mm and an applicable lesion length of ≤40 mm.
System Overview and Components
The drug-eluting stent system comprises a drug-coated stent and a rapid-exchange balloon catheter delivery system. The drug-coated stent is based on the L605 cobalt-chromium alloy stent, with a surface coating that includes a bottom layer and a drug-containing polymer coating. The bottom coating material is poly butyl methacrylate (PBuMA), which is non-degradable. The drug coating consists of rapamycin and polylactic-glycolic acid (PLGA), a degradable coating. The stent has a drug dose density of 1.20μg/mm² and a drug loading of 59-324μg.
Delivery System and Product Details
The delivery system includes a TIP head, balloon, marker, balloon inner tube, balloon outer tube, and handle. The product is sterilized using electron beam technology and is intended for single use. The shelf life of the product is 18 months.
Future Outlook
The market approval of Sino Medical Sciences’ drug-eluting stent system marks a significant advancement in the treatment of ischemic heart disease. This innovative system is expected to improve patient outcomes by effectively addressing vascular stenosis, a common issue in ischemic heart disease.-Fineline Info & Tech
