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…

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.

TGA Public Summary