Device Dossier
Envi™-SR - Embolectomy/thrombectomy suction catheter
Device Dossier for Envi™-SR - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter, Class III, sponsor SERVISTAR). ARTG…
- GMDN category: Embolectomy/thrombectomy suction catheter
Intended purpose
The Envi™-SR is intended for use 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 IV tPA or who fail IV tPA therapy are candidates for treatment.
Functional description
The Thrombectomy Suction Catheter is intended for use 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 IV tPA or who fail IV tPA therapy are candidates for treatment.