The Penumbra System™ is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. It is intended for use in the revascularisation of patients with acute ischaemic stroke secondary to intracranial large vessel occlusions. The Penumbra System includes ACE™68 Reperfusion Catheter, 3D Revascularization Device™, Penumbra ENGINE™ Aspiration Source, and accessories.
ACE68 Reperfusion Catheter is designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. The ACE catheter design further increases the distal and proximal lumen sizes, providing optimal trackability and even greater aspiration power.
The Penumbra System is comprised of several devices:
- ACE68 Reperfusion Catheter
- 3D Revascularization Device
- Penumbra ENGINE
- Penumbra ENGINE Canister
- Aspiration Tubing