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Boston Scientific has received regulatory approval to manufacture an intravascular ultrasound catheter at its facility in Shanghai, marking the company’s first manufacturing license in China. The product, called OptiCross HD, is designed to be used alongside an endovascular ultrasound system, offering clinicians detailed intravascular imaging and precise measurement data during percutaneous coronary interventions. This enables healthcare providers to better evaluate vascular lesions and refine treatment strategies.
China faces a significant burden of cardiovascular disease, with approximately 330 million affected individuals, including around 11.4 million with coronary heart disease. The incidence continues to rise due to population aging. The number of percutaneous coronary interventions performed to treat coronary heart disease is also increasing, reaching about 1.9 million procedures in 2023.
Obtaining the registration certificate is a major step toward localizing Boston Scientific’s operations in China. The company aims to make high-definition intravascular ultrasound technology more readily available through domestic manufacturing, allowing more physicians to confidently diagnose and treat complex cases and ultimately improve patient outcomes.
As China’s healthcare market expands, international medical device firms are establishing local manufacturing facilities to meet rising demand. In 2024, Boston Scientific launched its first Chinese plant in the Lingang Special Area within the Shanghai Free Trade Zone. This facility features the country’s first fully automated production line for intravascular ultrasound catheters, with an annual capacity exceeding 10,000 units. The plant has also produced samples of devices used to treat atrial fibrillation and benign prostatic hyperplasia for regulatory testing.
The company plans to further develop its local manufacturing and innovation initiatives, with the Lingang plant playing a key role. Collaborating with Chinese medical experts, Boston Scientific aims to advance precision diagnosis and treatment for cardiovascular diseases, ensuring that more patients benefit from cutting-edge medical technology.
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