Device Dossier

HiPoint 70 Reperfusion Catheter with Tenzing 7 - Embolectomy/thrombectomy suction catheter

Device Dossier for HiPoint 70 Reperfusion Catheter with Tenzing 7 - Embolectomy/thrombectomy suction catheter (Embolectomy/thrombectomy suction catheter,…

Intended purpose

The Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within the internal carotid artery and middle cerebral artery M1 segment within 8 hours of symptom onset. Patients who are ineligible for thrombolytic drug therapy or who failed thrombolytic drug therapy are candidates for treatment.

Functional description

Delivery Catheter is single-lumen, variable stiffness with long, tapered tip and two radiopaque markers; proximal end has luer hub for use with Aspiration Catheter. Aspiration Catheter is single-lumen, coil-reinforced distal shaft section connected to proximal control wire and radiopaque marker at distal tip. Catheters have hydrophilic coating for movement. Clip provided to temporarily secure the Delivery Catheter to the Aspiration Catheter during delivery. To be used with the Base Camp Sheath.

TGA Public Summary