MicroPort NeuroScientific Corporation has announced that its Apollo Dream sirolimus target-eluting stent system has been granted Breakthrough Device designation by the US Food and Drug Administration (FDA), providing opportunities for early and frequent interaction with the US regulator as development of the system progresses.
As detailed in a company press release, intracranial atherosclerotic disease (ICAD) is a leading cause of ischaemic stroke worldwide and remains “one of the most challenging areas in cerebrovascular therapy”. Patients with medically refractory ICAD face limited treatment options, and effective interventional approaches to restore cerebral blood flow represent a “significant unmet clinical need”.
To this end, Apollo Dream—MicroPort NeuroScientific’s investigational, balloon-expandable, rapid-exchange drug-eluting stent system—has been designed to provide vascular scaffolding and restore cerebral blood flow. The company says it is not aware of any other devices with this specific combination of features that have received a US FDA Breakthrough Device designation covering this indication.
The system incorporates a proprietary ‘microgroove’ drug-delivery architecture, whereby 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.
MicroPort NeuroScientific notes that Apollo Dream’s drug load is lower as compared to traditional drug-eluting stents. Long-term safety outcomes with this stent system are currently under clinical investigation, the company adds, also highlighting the fact that Apollo Dream remains an investigational device that is yet to receive full US FDA approval or clearance for commercial distribution in the USA.
