On March 18, MicroPort announced that its independently developed APOLLODream® rapamycin-eluting stent system recently received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), becoming the world's first balloon-expandable, fast-exchange drug-eluting stent in the neurointerventional field to receive this designation.
This system is specifically designed for patients with symptomatic intracranial arterial stenosis who have not responded to existing best-practice drug therapy. It precisely controls the drug release dose and significantly reduces the total drug load entering the body. Breakthrough Device Designation is awarded to innovative medical technologies developed for diseases that are life-threatening or cause irreversible functional impairment and have the potential for significant clinical advantage.
The recognition of the APOLLODream® stent system's technological innovation and potential clinical value in the treatment of intracranial atherosclerotic stenosis by an internationally authoritative regulatory agency is expected to accelerate the device's clinical development and review process and is expected to fill the gap in the overseas market for drug-eluting stents for the treatment of intracranial atherosclerotic stenosis. The company will continue to advance the global clinical research and registration process of this stent system, further expanding its international influence in the field of innovative neurointerventional treatments.
