AccuMedical Beijing Ltd has secured approval from China’s National Medical Products Administration (NMPA) for its blood flow-guided dense mesh stent, marking it as the 181st novel medical device approved in the country. The stent is indicated for the treatment of unruptured saccular or spindle wide-necked aneurysms in the internal carotid artery (from the petrous bone segment to the end) and vertebral artery, where the aneurysm neck width is ≥ 4mm or the aneurysm body-to-neck ratio is <2. The device is designed for use in blood vessels with diameters ranging from 2.0mm to 5.6mm.
Innovative Design and Functionality
The blood flow-guided dense mesh stent is a cylindrical self-expanding implant woven from cobalt-chromium and platinum-tungsten alloy wires. Its delivery system includes a push rod, stainless steel coil, funnel, support pad, braided pipe, marking ring, platinum coil, warning mark, heat-shrinkable pipe, and adhesive. A key innovation is the integration of a mechanical balloon within the delivery system, which actively assists in stent expansion from the inside, ensuring precise placement at the treatment site. The system also allows for stent retrieval if necessary, enhancing procedural flexibility and safety.
Addressing Complex Aneurysms
This approval underscores AccuMedical’s commitment to advancing treatments for complex vascular conditions. The stent’s dense mesh design and flow-guided technology aim to improve outcomes for patients with challenging aneurysms, particularly in the carotid and vertebral arteries. By combining innovative materials with advanced delivery mechanisms, the device represents a significant step forward in endovascular therapy.-Fineline Info & Tech
