Randomized Penumbra 3D Trial of Next-Gen Stent Retriever Meets Primary Endpoints

Penumbra, Inc. a global interventional therapies company, today announced that the Penumbra 3D Trial successfully met the primary trial endpoints, demonstrating non-inferiority in both safety and efficacy of the company’s next-generation stent retriever, Penumbra 3D Revascularization Device, when used with Penumbra System aspiration devices compared to Penumbra System aspiration devices alone. The data were presented in the Late Breaking Abstract Presentations session today at the Society of NeuroInterventional Surgery (SNIS) 13th Annual Meeting in Boston, Massachusetts.
 
Results showed non-inferior revascularization rates according to the FDA-defined primary effectiveness measure of TICI 2-3 in the Penumbra 3D Revascularization Device with Penumbra System aspiration devices arm (3D+aspiration device arm) compared to the Penumbra System aspiration devices only arm (aspiration device-only arm) (88.5 percent vs. 85.9 percent). In addition, the more strictly defined revascularization measure, TICI 2b/3, showed non-inferiority between the 3D+aspiration device arm and the aspiration device-only arm (83.9 percent vs. 74.1 percent). The primary safety endpoints—device-related serious adverse events (SAEs) and procedure-related SAEs—were not statistically different between the two arms (p=1.0 and p=0.4920, respectively).
 
“The results of the Penumbra 3D Trial speak positively on the use of Penumbra’s 3D Revascularization Device in combination with the Penumbra System aspiration devices, as well as on the use of Penumbra System aspiration devices alone,” said Donald Frei, MD, lead investigator of the study and director, NeuroInterventional Surgery at Radiology Imaging Associates/Swedish Medical Center in Englewood, Colorado. “The data also suggest that the revascularization rate in the Penumbra 3D plus aspiration device arm and the aspiration device-only arm—83.9 and 74.1 percent, respectively—compare favorably to the 71 percent revascularization rate published in the HERMES meta-analysis of five major randomized controlled trials in acute ischemic stroke.”
 
Patients in both arms experienced similar rates of return to functional independence (mRS=2 at 90 days): 41.6 percent in the 3D+aspiration device arm and 48.8 percent in the aspiration device-only arm (p=0.4260). These clinical outcomes were obtained without the benefit of selecting patients using imaging techniques designed to detect viable brain tissue.
 
“The trial results are encouraging for our Penumbra 3D Revascularization Device, and we are focused on continuing our plan to pursue regulatory submission by the end of this year,” said Adam Elsesser, chairman and chief executive officer of Penumbra. “Furthermore, the broader implications of the data support frontline use of the Penumbra System direct aspiration devices in the revascularization of stroke patients.”