Recently, the Biolimus-coated coronary balloon catheter, an innovative product of Shandong JW Medical Systems Ltd., is approved for marketing by China NMPA. 

The Biolimus-coated coronary balloon catheter consists of balloon catheter and drug coating on the balloon. The balloon catheter consists of balloon, distal shaft, transition shaft and proximal shaft, etc. The drug coating contains Biolimus drug and a polyethylene oxide (PEO) carrier at a drug dose of 3 μg/mm2. The product is sterilized by ethylene oxide and for single-use. PEO acts as a carrier to support the adhesion of drug to the balloon surface. The hydrophilic property of PEO and the lipophilic property of Biolimus allow the drug to be released from the balloon surface and transfer to the vessel rapidly.

As an intravascular drug delivery technique, drug-coated balloon is able to release drug at target lesion with therapeutically effective concentration, to solve and treat coronary heart disease intervention and in-stent restenosis. This product is applicable for treatment of de novo coronary artery lesion with vessel diameter of 2.0 mm - 2.75 mm, providing a new option for the patients with de novo small vessel lesion.

The NMPA will strengthen the post-marketing surveillance on the product to protect the patient safety.

近日，国家药品监督管理局经审查，批准了山东吉威医疗制品有限公司生产的创新产品“优美莫司涂层冠状动脉球囊扩张导管”注册。

优美莫司涂层冠状动脉球囊扩张导管由球囊扩张导管及球囊上的药物涂层组成，球囊导管由球囊、远端管、过渡管和近端管等组成。药物涂层含有优美莫司和聚环氧乙烷载体，药物剂量为3μg/mm2。产品经环氧乙烷灭菌，一次性使用。该产品通过聚环氧乙烷载体将优美莫司药物粘附在球囊表面，聚环氧乙烷的亲水特性和优美莫司的亲脂特性使药物可以从球囊表面释放并快速进入血管壁。

药物球囊作为一种血管内药物释放技术，能在病变部位释放有效治疗浓度的药物，解决并治疗冠心病介入及支架内再狭窄病变。该产品适用于血管直径2.0mm-2.75mm原发冠状动脉血管病变治疗，为原发小血管病变患者提供了新的选择。

药品监督管理部门将加强该产品上市后监管，保护患者用械安全。