Anaconda Biomed publishes ANAIS study results

Anaconda Biomed, S.L. has announced that results of the ANAIS Study, which evaluated the safety and performance of its ANA funnel catheter in the endovascular treatment of large vessel occlusion acute ischemic stroke, have been published in the American Journal of Neuroradiology. The 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 the treatment of 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.

The ANAIS study evaluated the safety and performance of Anaconda Biomed’s ANA funnel catheter, a novel device 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 percent of patients in the intention-to-treat (ITT) population and 81 percent 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 percent of the cases, with successful reperfusion within three passes in 100 percent of 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 randomised stroke trial to include FPE as a primary outcome measure,” said Hendrik Lambert, Chief Medical Officer at Anaconda Biomed.

The ANA5 is a funnel catheter designed to assist in 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 diameter of the target artery.

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