US medical product provider Boston Scientific has marked a new milestone in its China localization journey, with its production base in Shanghai's Lin-gang Special Area playing a central role.

Boston Scientific's production base in Lin-gang Special Area. [Photo/Wenhui Daily]

The company announced on March 13 that its OptiCross HD intravascular ultrasound (IVUS) catheter has received approval from China's National Medical Products Administration. This marks a significant milestone as it will be locally manufactured at the company's Lin-gang production base, making it the first domestically approved medical device to be produced at this facility.

OptiCross HD is China's first approved 60MHz high-definition IVUS catheter. Designed for use in percutaneous coronary intervention (PCI) procedures, it delivers high-resolution intravascular imaging and precise measurements, assisting physicians in their work.

IVUS plays a critical role in PCI, providing real-time vessel imaging that helps physicians assess lesions more accurately. Despite its clinical value, IVUS is used in only about 18 percent of PCI procedures in China.

OptiCross catheters have been used in landmark IVUS clinical studies cited in both domestic and international guidelines. Local manufacturing of OptiCross HD is expected to expand the clinical reach of high-definition IVUS technology across China.

As Boston Scientific's first manufacturing base in China, the Lin-gang facility aims to accelerate local access to advanced medical technologies. It has established a dedicated automated production line for OptiCross HD.

With the IVUS system already manufactured locally, the approval of OptiCross HD finalizes Boston Scientific's local production setup in China. The milestone strengthens Lin-gang's role as a key node in Boston Scientific's global supply chain, while also supporting the development of high-performance medical device manufacturing in China.