The Penumbra System® is a fully-integrated system designed specifically for mechanical thrombectomy by aspiration, first receiving 510(k) clearance by the FDA in December 2007. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. The Penumbra System includes reperfusion catheters, 3D Revascularization Device™, the Penumbra ENGINE™ aspiration source, and accessories.
The latest generation of the Penumbra System features the Penumbra JET™ Reperfusion Catheters, Hi-Flow Aspiration Tubing, and the 3D Revascularization Device. Launched in 2017, the 3D Revascularization Device is designed and optimized for aspiration with Penumbra JET and ACE™ Reperfusion Catheters.