MicroPort wins FDA breakthrough nod for drug-eluting stent

MicroPort announced that it received FDA breakthrough device designation for its Apollo Dream sirolimus target-eluting stent system.

Apollo Dream,  an investigational, balloon-expandable, rapid-exchange drug-eluting stent system, is designed to provide vascular scaffolding and restore. cerebral blood flow. It aims to treat intracranial atherosclerotic disease (ICAD), a leading cause of ischemic stroke.

The stent incorporates a proprietary microgroove drug delivery architecture. Sirolimus and a bioabsorbable polymer precisely fit within micron-sized grooves on the abluminal (vessel wall-facing) surface of the stent. The luminal (blood-facing) surface remains in a bare-metal state.

As the polymer degrades, sirolimus goes to the vessel wall. The company said its drug load registers lower than traditional drug-eluting stents.

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