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Clinical Trials and Data

Penumbra System^® Data

Enrolling Trials

THERAPY Trial
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.

3D Trial
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.

Completed Trials

POST Trial
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.

Penumbra Coil 400^™ Data

Patel et al report their early single-center experience with Penumbra Coil 400™, and compare it to their results with conventional coils. They concluded that compared with conventional coils, the Penumbra Coil 400 is more efficient in the embolization of cerebral aneurysms, achieving greater packing density (36.8% vs 28.1%; p<0.005) with fewer coils (an average of 3.9 vs 6.1 coils per aneurysm; p<0.05)and less time (45.7 vs 64.1 min; p<0.05) without compromising safety. See the Patel, et al abstract from JNIS here.

Milburn et al report their single-center experience with the Penumbra Coil 400, and compare it to their results with conventional coils. In consecutive cases, they report a >90% rate of stable occlusion on average follow-up time of 8.6 months. They evaluate and compare the number and total length of coils used per unit volume of aneurysm. They predict a 67% cost savings using the Penumbra Coil 400. See the Milburn, et al abstract from JNIS here.

Neuron^™ and Access Device Data

Turk, et al published a review of 659 procedures over four years from October 2007 to November 2011. They retrospectively compared their experience with conventional guide catheters to the Neuron 053 and Neuron 070. They concluded that the Neuron family was more trackable and that it allowed distal access with a high rate of success while maintaining a low rate of complications. They also found that when a true intracranial location was achieved with Neuron, that fewer complications occurred. See a summary Slide here—or review the abstract here.

Please contact your local Penumbra representative if you have any questions.

See

bibliography

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