The FDA has granted 510(k) clearance for the Penumbra System, which is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of symptom onset.

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, working on the proximal surface of the occlusion, Penumbra said. 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, according to the company.

The San Leandro, Calif.-based Penumbra said it will commence the immediate commercialization of the device in the United States.