Trial Finds Penumbra’s RED 43 Aspiration Catheter Safe and Effective for Thrombectomy of Distal Medium Vessel Occlusions in Acute Ischemic Stroke

A new analysis of more than 100 acute ischemic stroke patients presenting with distal medium vessel occlusion (DMVO) found that aspiration thrombectomy using Penumbra’s RED^® 43 catheter is safe and effective, with high recanalization rates and a favorable safety profile. The research was led by Dr. Nitin Goyal M.D., an endovascular neurologist at Semmes-Murphey Neurologic and Spine Institute in Memphis, Tenn., and was published in the Journal of NeuroInterventional Surgery.

“Our study provides compelling evidence supporting the safety and efficacy of the RED 43 catheter,” wrote Dr. Goyal and his colleagues. “By demonstrating robust recanalization rates and favorable functional outcomes with minimal complications, the findings highlight the potential of this catheter to improve care for patients with acute ischemic stroke due to DMVOs.”

DMVOs represent about 25-40% of all acute ischemic strokes, yet there are limited options and no clear consensus for the optimal management for these stroke patients. Mechanical thrombectomy is the standard of care for managing large vessel occlusions. A few recent RCTs of predominantly stent-retriever based approaches raised concerns about the efficacy and safety, particularly increased rates of symptomatic intracerebral hemorrhage. This trial provides new evidence affirming the safety and efficacy of aspiration thrombectomy for DMVOs.

Goyal and his colleagues conducted a retrospective multi-center study of a cohort of consecutive patients with anterior and posterior circulation DMVOs presenting within 24 hours of symptoms onset who underwent primary aspiration thrombectomy using the RED 43 to explore the safety and efficacy of this approach. The RED 43 catheter was specifically designed for distal access and navigation of the cerebral vasculature and supports direct aspiration.

First pass success (mTICI 2c or 3 on the first pass) was achieved in 57% of patients with a primary DMVO. Successful recanalization (mTICI≥2b at end of procedure) was reported for 83% of patients presenting with primary DMVO, and 58% experienced good functional outcomes. Reports of complications were low, including a symptomatic intracerebral hemorrhage rate of just 1%. The median puncture-to-recanalization time was 24 minutes and the median number of passes for the entire cohort was one.

“The RED 43 catheter’s ability to navigate distal vasculature while providing effective aspiration makes it a valuable tool” for managing DMVOs, the authors conclude. “Its efficiency is demonstrated by a short median groin puncture-to-recanalization time, minimal need for stent-retriever anchoring, comparable FPE rates, low complication rates, and a reduced requirement for rescue treatment, highlighting its practicality in clinical settings.”

Important Safety Information

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The clinical results presented herein are for informational purposes only, and may not be predictive for all patients. Individual results may vary depending on patient-specific attributes and other factors. Risk information can be found at http://www.peninc.info/risk.

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