The Penumbra System™ is a fully-integrated system designed specifically for mechanical thrombectomy by aspiration. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions.
The Penumbra System is comprised of several devices:
- Penumbra JET™ 7 and Penumbra JET D Reperfusion Catheters
- ACE™ Reperfusion Catheters
- MAX™ Reperfusion Catheters
- 3D Revascularization Device™
- Penumbra ENGINE™ aspiration source
- Penumbra ENGINE Canister
- Hi-Flow Aspiration Tubing
Penumbra ENGINE delivers high vacuum through Penumbra Hi-Flow Aspiration Tubing, and Penumbra JET 7, Penumbra JET D, ACE and MAX Reperfusion Catheters. The Penumbra System is engineered to maximise aspiration power for clot removal. The 3D Revascularization Device is designed for aspiration with Penumbra JET 7 and 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.
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; radiation exposure that may lead to cataracts, skin reddening or burns from x-ray exposure.
Indication For Use
Penumbra ENGINE – Intended Use
The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems.
- Simple setup and design for revascularisation with Penumbra JET 7 and 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
- Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 in Hg or 98.2 kPa) with the disposable Penumbra ENGINE Canister
- The Penumbra System is an integrated system for use with other components of the Penumbra System, including Reperfusion Catheters, 3D Revascularization Device, Hi-Flow Aspiration Tubing, Penumbra ENGINE, and Penumbra ENGINE Canister