By Fineline Cube 
ZhongKe Yian Medical Technology (Beijing) Co., Ltd. has secured approval from China’s National Medical Products Administration (NMPA) for its sirolimus-eluting coronary stent system. This innovation is designed for patients with ischemic heart disease presenting with de-novo coronary lesions.
Product Specifications
The stent system comprises a pre-mounted drug-coated stent and a rapid-exchange balloon-delivery catheter. It is specifically indicated for lesions ≤30 mm in length and reference-vessel diameters ranging from 2.5 mm to 4.0 mm. The metal platform is fabricated from high-nitrogen, nickel-free stainless steel, addressing concerns related to nickel hypersensitivity, carcinogenicity, and teratogenicity associated with conventional alloys. The polymer-free drug layer combines sirolimus with a biodegradable PLGA carrier at a dose density of 100 μg per centimeter of stent length.
Regulatory Milestone
This approval marks Zhongke Yian’s device as the 361st “innovative medical device” sanctioned under China’s fast-track pathway, underscoring its significance in the medical device landscape.-Fineline Info & Tech