Results from the ANAIS study conducted by Anaconda Biomed published in the American Journal of Neuroradiology
Anaconda Biomed's ANA5 Funnel Catheter Gains European Approval, Enters Pivotal Clinical Trial
Anaconda Biomed, a leading medical device company, has made significant strides in the field of neurovascular procedures with the development of its ANA5 Funnel Catheter. The device, designed for endovascular treatment of large vessel occlusion acute ischemic stroke, has recently received CE Mark approval in Europe and is currently being evaluated in the global, FDA-approved clinical trial named ATHENA.
The ANAIS Study, published in the American Journal of Neuroradiology, demonstrated the safety and performance of Anaconda Biomed's ANA funnel catheter. In the ANAIS study, 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. Notably, no severe device-related adverse events or symptomatic intracranial hemorrhages were observed at 24 hours.
Dr. Alejandro Tomasello, principal investigator and Head of Neurointerventional Neuroradiology at Vall d'Hebron Hospital, Barcelona, hailed the ANAIS results as a significant step forward in refining mechanical thrombectomy interventions. Hendrik Lambert, Chief Medical Officer at Anaconda Biomed, expressed gratitude to the investigators, centers, and patients who contributed to the ANAIS study.
The ANA5 catheter, a novel device, features a radiopaque, self-expanding funnel covered with a continuous sealing coating. The sealing coating enables temporary local flow restriction upon deployment, facilitating the delivery of intravascular devices such as stent retrievers and microcatheters. The vessel-matching diameter funnel of the ANA5 catheter is designed to maximize the capture of blood clots during mechanical thrombectomy, potentially improving outcomes in acute ischemic stroke treatment.
The high rates of FPE from the ANAIS study are encouraging and are being implemented in the ongoing ATHENA clinical trial. As of July 2025, Anaconda Biomed has secured CE mark approval, allowing clinical and commercial use in Europe. The company has also enrolled the first U.S. patient in the ATHENA study.
The ATHENA trial, a global, FDA-approved randomized controlled trial, aims to provide definitive clinical data on the ANA5 catheter’s safety and effectiveness. The trial's completion will mark a significant step towards broader clinical adoption of the ANA5 catheter.
In summary, Anaconda Biomed’s ANA5 funnel catheter has entered a pivotal FDA-approved clinical trial named ATHENA, and it has recently received European regulatory clearance in mid-2025, marking significant progress in its development for acute ischemic stroke therapy. The large lumen of the ANA5 catheter matches the diameter of the target artery, potentially enhancing clot removal during thrombectomy procedures. The high success rates observed in the ANAIS study are promising indicators for the potential impact of the ANA5 catheter in the treatment of acute ischemic stroke.
[1] Anaconda Biomed Announces CE Mark Approval and First U.S. Patient Enrollment in ATHENA Study
[2] ATHENA: A Global Pivotal Trial of the ANA5 Funnel Catheter for Acute Ischemic Stroke
[1] Anaconda Biomed's ANA5 Funnel Catheter, recently approved for use in Europe, is currently being assessed in the global ATHENA trial for its effectiveness in treating neurological disorders such as acute ischemic stroke, a health-and-wellness concern that affects many people.
[2] In the health-and-wellness field, especially medical-conditions related to the brain like neurological disorders, the ongoing ATHENA trial could potentially revolutionize the treatment of acute ischemic stroke with the use of Anaconda Biomed's ANA5 Funnel Catheter, a novel device designed for endovascular treatment.
