THERAPY, The Randomized, Concurrent Controlled Trial to Assess the Penumbra System’s Safety and Effectiveness in the Treatment of Acute Stroke is designed to assess the Penumbra System as adjunctive treatment to IV rtPA in patients with acute ischemic stroke from large vessel occlusion. It is a prospective, randomized, concurrent controlled study of patients presenting with symptoms of acute ischemic stroke in the anterior circulation. Patients will be assigned to either IV rtPA therapy alone or a combined IV rtPA therapy and intra-arterial (IA) treatment with the Penumbra System. Each treated patient will be followed and assessed for 3 months after randomization.
The THERAPY trial has Investigational Device Exemption (IDE) approval from the FDA, and is actively enrolling patients.
The 3D Trial is a prospective, randomized control study that compares the safety and effectiveness of the novel Separator 3D as part of the Penumbra System with that of the standard Penumbra System alone. The Separator 3D is a next generation clot-securing device, which aids aspiration thrombectomy through the Penumbra System family of catheters for the revascularization of large vessel occlusion.
The 3D Trial has Investigational Device Exemption (IDE) approval from the FDA, and is actively enrolling patients.
Penumbra POST is a retrospective, multi-center study that represents the first organized review of real world experience with the Penumbra System®. Seven international centers enrolled 152 consecutive patients. Eighty-seven percent of patients treated with the Penumbra System
achieved TIMI 2-3 and 41% attained mRS ≤ 2 at 90 days.
Penumbra POST results from real world experience support and improve on the success by investigators in the Penumbra Phase I Study and Penumbra Pivotal Trial. The Penumbra POST article
and PowerPoint presentation
are available for download.
Since the introduction of the Penumbra System (2006 in Europe and 2008 in the United States), physicians have been adding to the growing body of clinical evidence on the Penumbra System. For articles and abstracts on the Penumbra System, see the bibliography