(Yicai) March 16 -- Boston Scientific has obtained regulatory approval to produce an intravascular ultrasound catheter at its plant in Shanghai, the US medical device giant's first manufacturing license in China.

The OptiCross HD can be used in conjunction with the endovascular ultrasound system to provide doctors with clear intravascular imaging and accurate measurement data in percutaneous coronary interventions, helping them more thoroughly assess vascular lesions and optimize treatment strategies, Boston Scientific said on March 13.

China has about 330 million people with cardiovascular disease, including about 11.4 million with coronary heart disease, while the incidence continues to rise as the population ages, according to data disclosed by Boston Scientific. The number of percutaneous coronary interventions for the treatment of CHD is also growing, reaching 1.9 million in 2023.

The registration certificate marks a key step in Boston Scientific's China localization, said Zhang Jun, president of the firm's country arm. The company hopes to make high-definition intravascular ultrasound diagnostic technology more accessible through localized production, helping more doctors make more confident treatment decisions in complex cases, improving the long-term prognosis of patients, she said.

With the continuous expansion of China's healthcare market, multinational companies have moved to build local factories to meet growing demand. In 2024, Boston Scientific's first Chinese plant went live in the Lingang Special Area, a key testing ground for economic and trade policies within the Shanghai Free Trade Zone, a year after it was announced.

The Lingang factory has the first automated production line for intravascular ultrasound catheters in China, with an annual production capacity exceeding 10,000 units, Boston Scientific said to Yicai. The plant has also rolled off several product samples for type inspection, including medical devices for the treatment of atrial fibrillation and benign prostatic hyperplasia, it added.

Boston Scientific will continue to deepen its local manufacturing and innovation layout, with the Lingang factory as an important pillar, Zhang noted. The company will work with Chinese experts to promote the development of precision diagnosis and treatment of cardiovascular diseases, so that more patients can benefit from advanced medical technology, she stressed.

Editors: Dou Shicong, Martin Kadiev