Device Dossier
Surpass Elite Flow Diverter System - Stent, vascular, intracranial
Device Dossier for Surpass Elite Flow Diverter System - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Stryker). ARTG…
- GMDN category: Stent, vascular, intracranial
- Sponsor: Stryker
Intended purpose
The flow diverter is intended to divert blood flow from entering an aneurysm sac from the parent artery. The Surpass Elite Flow Diverter System is indicated for use for the treatment of saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter ≥ 2.5 mm and ≤ 5.25 mm.
Functional description
The Surpass Elite Flow Diverter System is comprised of a self-expandable braided implant pre-loaded on the delivery wire, inside the introducer sheath. Once released from the constraint of the microcatheter into the vessel, the implant expands to the vessel lumen diameter and can be recaptured and repositioned prior to full deployment, if needed. In its expanded shape, the implant diverts the blood flow away from the aneurysm.