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Intracranial Aneurysm Embolization Assist Stent Approved for Marketing

CCFDIE| Updated: 2025-02-19

     

Recently, the innovative product "Intracranial Aneurysm Embolization Assist Stent" of Shanghai HeartCare Medical Technology Co., Ltd. is approved by China NMPA.

The product consists of three parts: the stent, delivery wire, and introducer sheath. The stent is laser-etched from nitinol tubing and features platinum-iridium markers at both ends and in the middle of some models, facilitating precise clinical assessment of stent deployment and wall apposition. Under standard clinical interventional surgical conditions, the stent is used in conjunction with angiography to determine the location of intracranial aneurysms, aiding in the endovascular embolization and blood flow reconstruction for patients with intracranial aneurysms.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.