颅内自膨式药物洗脱支架(COMETIU)
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赛诺医疗:COMETIU国内注册未获批原因及后续推进情况
Xin Lang Cai Jing· 2025-10-31 09:41
Group 1 - The core issue regarding the company's intracranial self-expanding drug-eluting stent registration application is that it was not approved due to the review department's concerns about the study design, which was deemed insufficient to evaluate the product's safety and efficacy [1] - The review department recommended conducting a randomized controlled study with the stent to address these concerns [1] - The company plans to maintain active and efficient communication with the regulatory agency to expedite the clinical and commercialization processes for the product both domestically and globally [1]