China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced receiving market approval for its next-generation drug-eluting stent system, BuMA Supreme, in Indonesia. The product is approved for use in improving the symptoms of vascular stenosis and will be eligible for marketing until October 19, 2027.
Composition and Design of the Drug-Eluting Stent System
The drug-eluting stent system comprises a drug-coated stent and a rapid-exchange balloon catheter delivery system. The stent is based on the L605 cobalt-chromium alloy and features a dual coating system. The bottom coating is made of poly butyl methacrylate (PBuMA), a non-degradable material, while the drug coating consists of rapamycin and polylactic-glycolic acid (PLGA), which is degradable. The stent is suitable for vessels with a diameter of 2.25-4.00mm and a lesion length of 40mm or less.
Advantages and Long-Term Safety of BuMA Supreme
BuMA Supreme is designed to accelerate the recovery of vascular endothelium following stent implantation. It achieves precise release of antiproliferative drugs and polymer degradation through a new drug release curve, minimizing the natural growth inhibition of endothelium. This innovation reduces the long-term catch-up effect and adverse event incidence associated with traditional drug-eluting stents (DES), thereby improving the long-term safety of the product. The product previously obtained marketing approval in China in September 2022, marking a significant milestone in its global expansion.-Fineline Info & Tech
