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Shares of MicroPort Endovascular MedTech Group surged following news that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its innovative stent graft system. This designation is expected to expedite the device’s path to market approval.
The company’s stock closed at CNY111.80 (approximately USD16.30), reflecting a 10.2% increase. The broader Shanghai stock index rose by 0.5%, and the stock has climbed 22% since the end of last year.
The Hector Multi-Branch Thoracic Aortic Stent Graft System will now benefit from priority review, including an accelerated process due to its Breakthrough Device status. The company announced this in a filing made to the stock exchange yesterday.
The device is designed for minimally invasive procedures to treat thoracic aortic lesions affecting all three branches of the aortic arch. This advancement could expand endovascular options for patients, addressing an urgent clinical need by providing comprehensive surgical solutions.
Last July, the same device received a custom device certification from the European Union, leading to its launch for clinical use and marketing in Europe. However, it has not yet been approved for sale by regulatory agencies in China or the U.S.
The stent graft system has entered the pre-market clinical trial phase at multiple centers in China and has been accepted into the country’s green channel for innovative medical devices under regulatory review, according to the company’s latest annual earnings report.
Financially, the company saw a 12% increase in net profit last year, totaling CNY563 million (roughly USD78.3 million). Revenue also rose by 12%, reaching CNY1.4 billion (approximately USD187.8 million). This growth was driven by the launch of several innovative products in China, with overseas sales increasing over 55% to CNY250 million.
Aortic arch lesions are associated with extremely high clinical risks, including a mortality rate exceeding 80% if an aneurysm ruptures. Traditional open-chest surgeries are invasive, require lengthy recoveries, and pose a significant risk of nerve injury. Existing stent systems also carry considerable surgical and complication risks.
The new stent graft system offers a minimally invasive alternative, enabling the reconstruction of the aorta and its three major branches through endovascular procedures. Clinical results from multiple cases in Europe have been promising, according to the company’s website.
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