Results of ANAIS study by Anaconda Biomed published in the American Journal of Neuroradiology
The ANA5 Funnel Catheter, developed by Anaconda Biomed, S.L., is making significant strides in the treatment of acute ischemic stroke. This device, often used in combination with stent retrievers, has recently received CE Mark approval for its use in Europe.
The approval comes after the successful completion of the ANAIS Study, a single-arm feasibility study conducted across three centers in Spain. The study evaluated the safety and performance of Anaconda Biomed's ANA funnel catheter in endovascular treatment of large vessel occlusion acute ischemic stroke. The results of the ANAIS Study were published in the American Journal of Neuroradiology.
Notably, the ANA5 features a radiopaque, self-expanding funnel covered with a continuous sealing coating. This design enables temporary local flow restriction upon deployment, potentially enhancing clot removal during thrombectomy procedures.
In the ANAIS Study, forty-three patients were enrolled, with a median NIHSS score of 16 at admission. Successful reperfusion within three passes was achieved in 100% of the population when the ANA device was deployed in the ICA C2-C3 segment and continuous aspiration was applied. The primary efficacy endpoint of 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.
Encouragingly, no severe device-related adverse events or symptomatic intracranial hemorrhages were observed at 24 hours in the ANAIS Study. Hendrik Lambert, Chief Medical Officer at Anaconda Biomed, expressed gratitude to the investigators, centers, and patients who contributed to the study.
With the success of the ANAIS Study, Anaconda Biomed is now focusing on the ATHENA clinical trial. This global pivotal randomized controlled study, FDA-approved, is designed to demonstrate the safety and efficacy of the ANA5 funnel catheter. The device's vessel-matching diameter funnel is intended to maximize clot capture during mechanical thrombectomy.
Enrollment in the ATHENA trial is actively progressing, with the first U.S. patient recently enrolled, marking an important milestone for the study. The catheter aims to prevent clot breakage during stent-based clot removal, potentially improving clinical outcomes.
The company's leadership is also strengthening, with Dr. Charles Carignan being selected as Anaconda Biomed’s Board Chairman in late June 2025. This appointment coincides with ongoing enrollment in the global investigational device exemption (IDE) ATHENA trial, indicating strong corporate support during this critical phase of clinical development.
In summary, the ATHENA trial is actively enrolling patients globally, including in the US, with Anaconda Biomed’s ANA5 catheter recently receiving regulatory approvals and leadership bolstering the company's clinical development efforts. The trial's aim is to confirm the safety and effectiveness of the funnel catheter in improving mechanical thrombectomy outcomes for acute ischemic stroke patients.
The ANA5 Funnel Catheter, designed to enhance clot removal during thrombectomy procedures for acute ischemic stroke, is moving forward in health-and-wellness research, particularly in the field of neurological-disorders like stroke. The upcoming ATHENA clinical trial, a global study, aims to verify the safety and efficacy of this device, potentially improving outcomes for medical-conditions such as large vessel occlusion.
