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March 31, 2026
MicroPort NeuroScientific Apollo Dream Sirolimus Target-Eluting Stent Granted FDA Breakthrough Device Designation
KEY TAKEAWAYS
- MicroPort NeuroScientific’s Apollo Dream sirolimus target-eluting stent system for intracranial atherosclerotic disease was granted FDA Breakthrough Device designation.
- The balloon-expandable, rapid-exchange device is designed to provide intracranial scaffolding while delivering sirolimus from abluminal microgrooves with a bioabsorbable polymer.
- FDA Breakthrough Device designation facilitates development and review of medical devices, providing early and frequent interaction with the FDA.
March 31, 2026—MicroPort NeuroScientific Corporation announced that the company’s Apollo Dream sirolimus target-eluting stent system has been granted FDA Breakthrough Device designation.
According to MicroPort NeuroScientific, Apollo Dreams is an investigational balloon-expandable, rapid-exchange drug-eluting stent system designed to provide vascular scaffolding and restore cerebral blood flow for the treatment of intracranial atherosclerotic disease.
The system incorporates the company’s microgroove drug-delivery architecture. Sirolimus and a bioabsorbable polymer are precisely placed into micron-sized grooves on the abluminal surface of the stent, while the luminal surface remains in a bare-metal state. As the polymer degrades, sirolimus is delivered to the vessel wall. Apollo Dream’s drug load is lower than traditional drug-eluting stent, stated the company.
Long-term safety outcomes are under clinical investigation, advised MicroPort NeuroScientific.
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