Anaconda Biomed Shares Positive ANAIS Study Results

Anaconda Biomed S.L. is touting results of the ANAIS Study showing high reperfusion rates with its ANA funnel catheter in treating large vessel occlusion in acute ischemic stroke.

Published in the American Journal of Neuroradiology, the study evaluated the safety and performance of Anaconda Biomed’s ANA funnel catheter. Trial data demonstrated high rates of reperfusion and first-pass success with a strong safety profile, supporting the ANA device as an adjunct to stent retriever thrombectomy in treating acute ischemic stroke.

“The ANAIS results represent a significant step forward in refining mechanical thrombectomy interventions. By reducing the need for multiple passes, these advancements may ultimately translate into improved neurological outcomes after stroke,” said Dr. Alejandro Tomasello, principal investigator and head of Neurointerventional Neuroradiology at Vall d’Hebron Hospital, Barcelona.

Anaconda Biomed’s ANA funnel catheter is designed to work in conjunction with stent retrievers to arrest blood flow and reduce the risk for clot fragmentation during mechanical thrombectomy.

Conducted prospectively across three centers in Spain, ANAIS was a single-arm feasibility study with blinded outcome assessment by an independent imaging core lab and oversight by an independent data safety monitoring board. Forty-three patients were enrolled to receive thrombectomy within 24 hours of symptom onset, with a median NIHSS score of 16 at admission.

The primary efficacy endpoint—successful reperfusion (eTICI 2b50–3) within three passes—was achieved in 70% of patients in the intention-to-treat (ITT) population and 81% in the per-protocol (PP) population. No severe device-related adverse events or symptomatic intracranial hemorrhages were observed at 24 hours.

In addition, the study allowed investigators to explore optimal device deployment strategies. When the ANA device was deployed in the ICA C2-C3 segment and continuous aspiration was applied, first pass effect, or FPE, (eTICI 2c-3) was achieved in 83% of the cases, with successful reperfusion within three passes in all patients within this population.

“We are grateful to the investigators, centers, and patients who contributed to this study. The high rates of FPE are encouraging, and the optimal deployment techniques identified during ANAIS are now being implemented in the ongoing ATHENA clinical trial, the first randomized stroke trial to include FPE as a primary outcome measure,” Anaconda Biomed Chief Medical Officer Hendrik Lambert said.

The ANA5 is a funnel catheter designed to help with neurovascular procedures by facilitating the delivery of intravascular devices such as stent retrievers and microcatheters. It features a radiopaque, self-expanding funnel covered with a continuous sealing coating that enables temporary local flow restriction upon deployment.

During acute ischemic stroke thrombectomy procedures, especially in combination with stent retrievers, the funnel catheter may enhance clot removal due to its large lumen—matching the target artery’s diameter.

Anaconda Biomed is focused on the clinical and commercial development of its proprietary funnel catheter technology, for better enabling mechanical thrombectomy in acute ischemic stroke.