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中国微创医疗器械公司股价飙升，此前美国授予其新型支架突破性医疗器械资格 2026-03-02
Shares of MicroPort Endovascular MedTech Group surged after the Chinese aortic and peripheral vascular interventional medical devices maker said the US Food and Drug Administration granted Breakthrough Device Designation to its innovative stent graft system, which will likely speed up its market approval.
MicroPort closed 10.2 percent higher at 111.80 yuan (US$16.30) a share on March 2. The broader Shanghai stock market climbed 0.5 percent. The stock has soared 22 percent since the end of last year.
The Hector Multi-Branch Thoracic Aortic Stent Graft System will receive priority review and multiple benefits, including an accelerated review process following the Breakthrough Device Designation, Shanghai-based MicroPort said in a stock exchange filing late on March 1.
The device is intended for minimally invasive interventional treatment of thoracic aortic lesions involving all three branches of the aortic arch, MicroPort noted, adding that it can extend endovascular aortic treatment to the entire aortic arch, offering patients more comprehensive surgical options and addressing an urgent clinical need.
The European Union granted the Hector stent graft system a custom device certification last July. The device has since been launched for clinical use and promotion in Europe, but has not yet received marketing approval from regulators in China or the United States.
The stent graft system has entered the pre-market multi-center clinical trial phase in China and has been accepted into the green channel for innovative medical devices under Chinese regulatory review, MicroPort said in an annual earnings report on Feb. 28.
MicroPort's net profit rose 12 percent to 563 million yuan (US$78.3 million) last year from the previous year, with its revenue also jumping 12 percent to 1.4 billion yuan (US$187.8 million) thanks to the launch of multiple innovative products in China, according to the report. Overseas sales soared more than 55 percent to CNY250 million.
Aortic arch lesions carry extremely high clinical risks, with a mortality rate of over 80 percent in the event of aneurysm rupture. Traditional open-chest surgeries are highly invasive, require long recovery times, and carry a high risk of nerve injury, while existing stent systems involve very high surgical and complication risks.
However, MicroPort's new stent graft system enables minimally invasive endovascular treatment while achieving endovascular reconstruction of the aorta and the three major arch branches. It has achieved favorable outcomes in multiple clinical cases performed in Europe, according to the website of the company.
Source: Yicai Global
