The National Medical Products Administration of China recently approved the registration application for the innovative product of the country's first domestically produced aneurysm embolization stent, marking a significant milestone in the medical device industry.

The product, developed and manufactured by Shanghai HeartCare Medical Technology Co Ltd in the Lin-gang Special Area, is designed for intracranial aneurysm embolization.

The approval represents the 10th Class III innovative medical device from a Shanghai-based enterprise to be approved for market this year. In total, Shanghai has witnessed the approval of five domestically produced Class I innovative drugs and 10 Class III innovative medical devices, surpassing the number of approvals recorded in the previous year.

The stent entered the national special review channel for innovative medical devices in March 2022. It comprises three main parts: the stent itself, a delivery guidewire, and an introducer sheath. The stent, crafted from nickel-titanium alloy tubing through laser cutting, features platinum-iridium marker points at both ends and in the middle of some models, facilitating precise clinical assessment of stent deployment and wall apposition.