Sequent Medical Inc. Announces NMPA Approval of Self-Expanding Intracranial Aneurysm Embolization System

On July 2, the National Medical Products Administration announced that, following review, it recently approved the registration of the innovative product "Self-Expanding Intra-Aneurysmal Embolization System" manufactured by Sequent Medical, Inc. (USA).

The product consists of an implant and a delivery guidewire. The implant is a self-expanding braided mesh structure composed of nitinol wires and platinum/nitinol composite wires. It is indicated for the endovascular treatment of adult patients with saccular wide-neck intracranial bifurcation aneurysms located at the middle cerebral artery bifurcation, terminal internal carotid artery, anterior communicating artery complex, or basilar artery apex, with an aneurysm diameter of 3 mm to 10 mm, a neck width ≥4 mm, or a dome-to-neck ratio >1 and <2.

Failure to achieve prompt or sustained occlusion of intracranial bifurcation wide-neck aneurysms may result in aneurysm rupture, posing a life-threatening risk. Following minimally invasive endovascular implantation, the implant self-expands to mechanically occlude the aneurysm and prevent blood inflow. This device provides a novel therapeutic option for the treatment of both ruptured and unruptured wide-neck bifurcation aneurysms, and eliminates the need for postoperative dual antiplatelet therapy (DAPT), thereby enhancing the safety profile. Currently, no other products with a similar design and intended use are commercially available in either domestic or international markets.

Appendix:List of Innovative Medical Devices Approved by the National Medical Products Administration.docx