The Penumbra System, a clot-retrieval technology that we were watching since 2006 while it was undergoing clinical trials, has received an FDA nod for use in the revascularization of patients with acute ischemic stroke.
The Penumbra System is a package of tools used by neuro interventional specialists to remove occlusions from the large vessels of the brain that are causing an acute ischemic stroke. It works on the proximal surface of the occlusion, optimizing safety and eliminating the need for navigation beyond the occlusion. The Penumbra System is comprised of an aspiration platform containing multiple devices that are size-matched to the specific neurovascular anatomy allowing clots to be gently aspirated out of intracranial vessels.
In the pivotal trial, in addition to the multiple aspiration devices, the system included a clot-grabbing device that was designed to be used if the aspiration devices were not successful. Based upon the results of the trial with the aspiration devices, and due to the small number of cases in which the clot-grabbing device was necessary, Penumbra, in consultation with the FDA, decided to exclude the clot-grabbing device from its final submission.
The Penumbra System is CE Marked and has been commercially available in Europe since June, 2007.
Press release: Penumbra, Inc. Announces 510(k) Clearance Of The Penumbra System™ For Use In The Revascularization Of Patients With Acute Ischemic Stroke.
Product page: Penumbra System
Flashback: More Neuroendovascular Fun: The Penumbra Stroke System