Device Dossier

Surpass Evolve Flow Diverter - Stent, vascular, intracranial

Device Dossier for Surpass Evolve Flow Diverter - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Stryker). ARTG record,…

Intended purpose

The flow diverter is intended to divert blood flow from entering an aneurysm sac from the parent artery. The Surpass Evolve Flow Diverter System is indicated for use for the treatment of saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter greater than or equal to 2.0mm and less than or equal to 5.0mm.

Functional description

The Surpass Evolve Flow Diverter System is comprised of a self-expandable braided implant preloaded on a delivery wire, housed inside an introducer sheath. Interwoven with the cobalt chromium wires of the implant are platinum-tungsten wires for visualization under fluoroscopy. Once released from the microcatheter into the vessel, the implant expands to the vessel lumen diameter and can be recaptured and repositioned for full deployment. The implant diverts the blood flow away from the aneurysm.

TGA Public Summary