Shanghai Xinhui Medical Technology Co., Ltd. Receives NMPA Approval for Innovative Intracranial Aneurysm Embolization Auxiliary Stent

Recently, the National Medical Products Administration approved the innovative product registration application for the "intracranial aneurysm embolization assist stent" from Shanghai HeartCare Medical Technology Co., Ltd.

The product consists of three parts: a stent, a delivery guidewire, and an introducer sheath. The stent is made from laser-cut nickel-titanium alloy tubing, with platinum-iridium marker points at both ends and in the middle section of some models to facilitate precise clinical assessment of stent deployment and wall apposition. Under standard interventional surgical conditions, the location of intracranial aneurysms is determined through angiography. It is used for endovascular adjunctive embolization and blood flow reconstruction in patients with intracranial aneurysms.

The pharmaceutical supervision and administration department will strengthen the post-marketing supervision of this product to protect the safety of patients using medical devices.

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Source: National Medical Products Administration