The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy by aspiration. It is intended for use in the revascularisation of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The Penumbra System includes Penumbra ACE and MAX Reperfusion Catheters, Hi-Flow Aspiration Tubing, 3D Revascularization Device, Penumbra Pump MAX aspiration source, and Penumbra MAX Canister.
Penumbra Pump MAX delivers high vacuum through Penumbra Hi-Flow Aspiration Tubing, and Penumbra ACE and MAX Reperfusion Catheters. The Penumbra System is engineered to maximise aspiration power for clot removal. The 3D Revascularization Device is designed and optimised for aspiration with Penumbra ACE Reperfusion Catheters.
Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use.
Indication For Use
Penumbra System – Intended Use
The Penumbra System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease using continuous aspiration.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; intracranial hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation.
Indication For Use
Penumbra Pump MAX – Intended Use
The Penumbra Pump MAX is intended as a vacuum source for the Penumbra Aspiration Systems.
- Simple setup and design for revascularisation with Penumbra ACE Reperfusion Catheters
- Hi-Flow Aspiration Tubing is designed to maximise aspiration power for clot removal with Penumbra Reperfusion Catheters
- 3D Revascularization Device is designed for use with aspiration and provides clot capture ability through four intraluminal chambers
- Pump MAX is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa)
- MAX Canister: disposable 1,000-ml collection canister
- The Penumbra System is an integrated system for use only with other components of the Penumbra System, including Reperfusion Catheters, Hi-Flow Aspiration Tubing, 3D Revascularization Device, Pump MAX, and MAX Canister