Core Viewpoint - Sino Medical (688108.SH) announced that its subsidiary, Sino Shenchang Medical Technology Co., Ltd., received breakthrough medical device designation from the FDA for its COMETIU self-expanding intracranial drug-coated stent system and COMEX balloon microcatheter, marking a significant milestone in the treatment of intracranial atherosclerotic stenosis [1] Group 1 - The COMETIU stent is the first product globally to receive FDA breakthrough designation for the treatment of intracranial atherosclerotic stenosis [1] - This designation is also the first for a domestic neurointerventional device in China, highlighting the company's innovation in ischemic stroke treatment [1] - The recognition from the FDA underscores the technical innovation and clinical advantages of the COMETIU product, filling a gap in the global market for treating intracranial atherosclerotic stenosis [1] Group 2 - The breakthrough designation is expected to enhance the company's international strategy and accelerate its global expansion efforts [1] - This achievement will significantly increase the company's international brand recognition and strengthen its core competitiveness in the neurointerventional field [1]