Anaconda Biomed 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 ischaemic stroke, have been published in the American Journal of Neuroradiology. The data demonstrate high rates of reperfusion and first-pass success with a strong safety profile, supporting the Ana device as an adjunct to stent retriever thrombectomy, according to Anaconda.
“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 principal investigator Alejandro Tomasello (Vall d’Hebron Hospital, Barcelona, Spain).
The ANAIS study evaluated the safety and performance of Anaconda’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 centres in Spain, ANAIS was a single-arm feasibility study with blinded-outcome assessment by an independent imaging core lab and oversight from an independent data safety monitoring board. Forty-three patients were enrolled to receive thrombectomy within 24 hours of symptom onset, with a median National Institutes of Health stroke scale (NIHSS) score of 16 at admission.
The primary efficacy endpoint—successful reperfusion (expanded thrombolysis in cerebral infarction [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 haemorrhages 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 internal carotid artery (ICA) C2–C3 segment and continuous aspiration was applied, first-pass effect (FPE; eTICI 2c–3) was achieved in 83% of cases, with successful reperfusion within three passes in 100% of this population.
“We are grateful to the investigators, centres 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.
