Device Dossier
Trevo XP ProVue Retriever - Embolectomy/thrombectomy suction catheter
Device Dossier for Trevo XP ProVue Retriever - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor…
- GMDN category: Embolectomy/thrombectomy suction catheter
- Sponsor: Stryker
Intended purpose
1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset. 2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. 3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age n≥80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.
Functional description
The Trevo Retriever is delivered to the thrombus using a microcatheter. The microcatheter is then retracted to deploy the shaped section of the Retriever within the clot. The Retriever and microcatheter are pulled back, engaging the thrombus in the shaped section of the Retriever. Time is allotted for the clot to integrate into the retriever. The Retriever, thrombus and the microcatheter are then removed from the body. The kit consists of the retriever, a torque device and an insertion tool.