Randomised trial of Penumbra 3D revascularisation device meets primary endpoints


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The Penumbra 3D trial of the company’s 3D revascularisation device has successfully met the primary trial endpoints, demonstrating non-inferiority in both safety and efficacy of the company’s next-generation stent retriever 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 at the Society of NeuroInterventional Surgery (SNIS) 13th Annual Meeting (25-28 July, Boston, USA).

Results showed non-inferior revascularisation rates according to the US Food and Drug Administration (FDA)-defined primary effectiveness measure of thrombolysis in cerebral infarction (TICI) 2-3 in the Penumbra 3D revascularisation device with Penumbra System aspiration devices arm (3D-plus-aspiration device arm) compared to the Penumbra System aspiration devices only arm (aspiration device-only arm) (88.5% vs. 85.9%). In addition, the more strictly defined revascularisation measure, TICI 2b/3, showed non-inferiority between the 3D-plus-aspiration device arm and the aspiration device-only arm (83.9% vs 74.1%). 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 revascularisation device in combination with the Penumbra System aspiration devices, as well as on the use of Penumbra System aspiration devices alone,” says Donald Frei, lead investigator of the study and director, NeuroInterventional Surgery at Radiology Imaging Associates/Swedish Medical Center in Englewood, USA. “The data also suggest that the revascularisation rate in the Penumbra 3D plus aspiration device arm and the aspiration device-only arm—83.9% and 74.1%, respectively—compare favourably to the 71% revascularisation rate published in the HERMES meta-analysis of five major randomised controlled trials in acute ischaemic stroke.”

Patients in both arms experienced similar rates of return to functional independence: 41.6% in the 3D-plus-aspiration device arm and 48.8% in the aspiration device-only arm (p=0.4260). These clinical outcomes were obtained without the selection of patients using imaging techniques designed to detect viable brain tissue.