Device Dossier
Aperio® Hybrid17/Hybrid21 Thrombectomy Device - Thrombectomy wire-net
Device Dossier for Aperio® Hybrid17/Hybrid21 Thrombectomy Device - Thrombectomy wire-net (Thrombectomy wire-net, Class III, sponsor Compliance Management…
- GMDN category: Thrombectomy wire-net
Intended purpose
The Aperio® Hybrid17/Hybrid21 Thrombectomy Device is designed to restore arterial blood flow in patients diagnosed with ischemic stroke due to the intracranial vessal occlusion. 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® Hybrid17/Hybrid21 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 are two radiopaque markers on the proximal end. Continuous radiopaque wires attached along the stent make it easier to place the device under fluoroscopy.