Device Dossier
Aperio® Hybrid Thrombectomy Device - Thrombectomy wire-net
Device Dossier for Aperio® Hybrid Thrombectomy Device - Thrombectomy wire-net (Thrombectomy wire-net, Class III, sponsor Compliance Management…
- GMDN category: Thrombectomy wire-net
Intended purpose
The Aperio® Hybrid Thrombectomy Device is intended for restoration of the arterial flow in patients diagnosed with ischemic stroke due to large intracranial vascular occlusion (i.e. in the internal carotid artery, M1 and M2 segments of the MCA). Patients who fail intravenous thrombolytic therapy or who are ineligible for thrombolysis may be suited for treatment with the Aperio® Hybrid Thrombectomy Device.
Functional description
The Aperio® Hybrid Thrombectomy Device consists of a self-expanding, laser-cut nitinol device, which is connected to a transport wire at its proximal end. The device is preloaded in an introducer. The device comprises 3 radiopaque markers at the distal end. There is a radiopaque marker on the proximal end. Continuous radiopaque wires attached along the stent make it easier to place the device under fluoroscopy.