China's First Peripheral Drug-Eluting Stent Receives NMPA Approval

On April 9, the National Medical Products Administration issued an announcement approving the registration of the priority product “Drug-Eluting Peripheral Vascular Stent” manufactured by Cook Ireland Ltd.

This product consists of a pre-loaded stent and delivery system, and includes syringe accessories. It is indicated for the treatment of symptomatic lesions in the above-knee femoropopliteal artery with reference vessel diameters of 4–9 mm.

This product is the first peripheral drug-eluting stent approved in China. It can support residual stenosis at the lesion site and reduce the occurrence of elastic recoil after balloon angioplasty. The paclitaxel coating inhibits vascular smooth muscle cell proliferation, thereby expected to reduce the incidence of restenosis. This product optimizes existing treatment regimens for peripheral vascular disease and better meets clinical needs.