Device Dossier
Credo Stent - Stent, vascular, intracranial
Device Dossier for Credo Stent - Stent, vascular, intracranial (Stent, vascular, intracranial, Class III, sponsor Compliance Management Solutions). ARTG…
- GMDN category: Stent, vascular, intracranial
Intended purpose
Used in combination with the NeuroSpeed® PTA Balloon Catheter, the CREDO® Stent is indicated to increase the vessel diameter of intracranial arteries (for example the ICA, MCA, VA/V4, BA) that are suitable for and accessible to the system (stent with PTA balloon catheter) in adult patients: •recurrent (2 or more) strokes refractory to a comprehensive regimen of medical therapy •atherosclerotic disease of intracranial vessels with >70% stenosis that are accessible to the system •most recent stroke must have occurred at least 7 days prior to treatment •Modified Rankin Score (mRS) is 3 or less at the time of treatment
Functional description
The Credo® Stent is a self-expanding, laser-cut nitinol stent,preloaded onto a transport wire in an introducer. The stent features a closed-cell design with 3 radiopaque markers eachat the proximal and distal end. To facilitate positioning under fluoroscopy, the transport wire is also equipped with 3 radiopaque markers.