MICROPORT NEURO's APOLLO Dream® Sirolimus-Targeted Eluting Stent System Receives FDA Breakthrough Device Designation

Stock News
Mar 18

MICROPORT NEURO (02172) announced that its independently developed APOLLO Dream® Sirolimus-Targeted Eluting Stent System (APOLLO Dream® Stent System) has recently been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This makes it the world's first balloon-expandable, rapid-exchange drug-eluting stent in the neurointerventional field to receive this designation. The APOLLO Dream® Stent System is specifically designed for patients with symptomatic intracranial arterial stenosis who have not responded to optimal medical therapy. The system integrates targeted drug-eluting technology with an optimized stent mechanical structure. It provides stable vascular support and restores cerebral blood flow, while simultaneously releasing sirolimus precisely to the vessel wall to inhibit vascular smooth muscle cell proliferation, thereby reducing the risk of postoperative restenosis. Compared to traditional drug-eluting stents, the APOLLO Dream® Stent System allows for more precise control of drug dosage, ensuring efficacy while significantly reducing the total drug load entering the body. Its drug coating utilizes biodegradable materials, which gradually degrade after completing drug release, helping to lower the long-term risk of thrombosis. The Breakthrough Device Designation is awarded to innovative medical technologies developed for diseases that are life-threatening or cause irreversible functional impairment, and which demonstrate potential for significant clinical advantages. As the first balloon-expandable, rapid-exchange drug-eluting stent in neurointervention to receive this recognition, the designation signifies that the technological innovation and potential clinical value of the APOLLO Dream® Stent System in treating intracranial atherosclerotic disease (ICAD) have been acknowledged by an international authoritative regulatory body. It will help accelerate the clinical development and review process for the device, has the potential to fill a gap in the overseas market for drug-eluting stents treating ICAD, benefiting patients worldwide, and lays an important foundation for the group to advance its global strategy and accelerate entry into key international markets. Moving forward, the group will continue to advance the global clinical research and registration process for the APOLLO Dream® Stent System, further expanding the company's international influence in the field of innovative neurointerventional therapies and providing more advanced treatment options for patients globally.

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