Device Dossier
pRESET/pRESET LITE Thrombectomy Devices - Thrombectomy wire-net
Device Dossier for pRESET/pRESET LITE Thrombectomy Devices - Thrombectomy wire-net (Thrombectomy wire-net, Class III, sponsor Emergo). ARTG record,…
- GMDN category: Thrombectomy wire-net
Intended purpose
The pRESET and pRESET LITE Thrombectomy Devices are indicated for mechanical clot retrieval from intracranial arteries as acute ischemic stroke treatment. Candidates for treatment are patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), patients who fail IV t-PA therapy and patients who require a supplement treatment to an initiated IV t-PA therapy.
Functional description
The pRESET/pRESET LITE Thrombectomy Devices consists of a self-expanding nitinol structure that carries one radiopaque platinum/iridium coil-marker on its proximal end and two markers on its distal end. The structure is firmly attached to a pusher wire on its proximal end. This pusher wire is covered with a PTFE tubing in order to reduce friction during use. The retrieval device is stored in compressed form in an introducer sheath.