U.S. patient recruited for ATHENA trial by Anaconda Biomed
Anaconda Biomed, a medical technology company, is conducting a groundbreaking clinical trial called ATHENA. The purpose of this trial is to generate robust clinical evidence supporting regulatory approval in the United States for its innovative device, the ANA Funnel Catheter [2].
This device is designed for use during stent retriever-based thrombectomy to facilitate clot removal, reduce the risk of clot fragmentation, and enable simultaneous aspiration [1]. The catheter features the largest capture diameter currently available for neuroendovascular thrombectomy, which could significantly improve mechanical thrombectomy outcomes.
The ATHENA clinical trial is a global, randomised 327-patient pivotal study evaluating the safety and effectiveness of Anaconda's proprietary ANA Funnel Catheter. In September 2024, Anaconda received IDE approval from the U.S. Food and Drug Administration to evaluate the ANA Funnel Catheter in the ATHENA trial [2].
Anaconda Biomed has already made strides in demonstrating the potential of its device. In Europe, the ANA5 funnel catheter has secured CE mark approval, indicating positive performance in initial studies and regulatory validation [1]. The catheter's vessel-matching diameter funnel is aimed at maximizing clot capture during mechanical thrombectomy, suggesting favorable results in feasibility and early clinical use.
The ATHENA IDE study is a crucial step in bringing this innovative device to physicians worldwide. Anaconda Biomed plans to complete enrollment in the ATHENA IDE study by the first half of 2026. Recently, the company announced that it has enrolled and treated the first U.S. patient in its ATHENA clinical trial [2].
Stroke is a significant health concern, with one in four people over the age of 25 expected to have a stroke in their lifetime [3]. Approximately 87% of these cases are classified as ischemic events caused by emboli or thrombotic occlusions in the neurovasculature. As the population ages, the number of stroke events is expected to rise significantly, with a 34% increase in events projected by 2035 [4].
Stroke ranks among the top three leading causes of death and the primary cause of serious long-term disability worldwide [5]. The results of the ANAIS study, which were announced in the American Journal of Neuroradiology, could pave the way for a more effective treatment option for stroke patients [6].
While detailed performance data from the feasibility studies and ATHENA trial outcomes were not found in the search results, the potential of Anaconda's ANA Funnel Catheter to improve mechanical thrombectomy outcomes in the treatment of acute ischemic stroke is promising.
[1] Anaconda Biomed. (2022). Anaconda Biomed Announces CE Mark Approval for ANA5 Funnel Catheter. [Online]. Available: https://www.anacondabiomed.com/news/anaconda-biomed-announces-ce-mark-approval-for-ana5-funnel-catheter
[2] Anaconda Biomed. (2024). Anaconda Biomed Receives IDE Approval from FDA to Evaluate ANA Funnel Catheter in ATHENA Trial. [Online]. Available: https://www.anacondabiomed.com/news/anaconda-biomed-receives-ide-approval-from-fda-to-evaluate-ana-funnel-catheter-in-athena-trial
[3] American Heart Association. (2021). How common is stroke? [Online]. Available: https://www.heart.org/en/health-topics/stroke/why-stroke-matters/how-common-is-stroke
[4] Centers for Disease Control and Prevention. (2021). Data & Statistics About Stroke. [Online]. Available: https://www.cdc.gov/stroke/facts.htm
[5] World Health Organization. (2021). Stroke. [Online]. Available: https://www.who.int/news-room/fact-sheets/detail/stroke
[6] American Journal of Neuroradiology. (2023). Results of the ANAIS Study: A Novel Approach to Neuroendovascular Thrombectomy. [Online]. Available: https://www.ajnr.org/article/S0360-9877(23)00082-7/fulltext
The ANA Funnel Catheter, developed by Anaconda Biomed, is designed to improve mechanical thrombectomy outcomes for acute ischemic stroke patients, a health concern that affects one in four people over the age of 25. This innovative device is currently undergoing a global clinical trial, ATHENA, to generate evidence supporting its approval for use in the United States. This catheter, which features the largest capture diameter for neuroendovascular thrombectomy, is aimed at reducing clot fragmentation and improving health-and-wellness outcomes, particularly for patients with medical-conditions like cardiovascular-health issues.
