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April 9, 2025
Anaconda Begins ATHENA Trial of ANA5 Funnel Catheter for Ischemic Stroke Treatment
April 9, 2025—Anaconda Biomed, SL, a developer of next-generation neurothrombectomy devices, recently announced the enrollment and treatment of the first United States patient in its ATHENA investigational device exemption (IDE) clinical trial. The patient was enrolled by Shahram Majidi, MD, an Associate Professor of Neurosurgery, Neurology, and Radiology at Icahn School of Medicine at Mount Sinai in New York, New York.
According to the company, ATHENA is a global, randomized 327-patient pivotal study evaluating the safety and effectiveness of Anaconda’s ANA5 advanced neurovascular access funnel catheter. The company received FDA approval for the IDE in September 2024. Conditional IDE approval was announced in July 2024. The IDE submission was supported by feasibility studies of the device that demonstrated high rates of reperfusion and first-pass success, along with a strong safety profile.
Anaconda Biomed advised it intends to complete enrollment in the ATHENA IDE study in the first half of 2026.
The ANA funnel catheter is designed for use during stent retriever-based thrombectomy to facilitate clot removal by restricting flow during retrieval, enabling simultaneous aspiration, and reducing the risk of clot fragmentation at capture in patients with large vessel occlusion acute ischemic stroke, stated the company.
“We have long recognized the impact of fast and complete reperfusion in stroke patients, and we are delighted to have initiated this important clinical trial for examining the role that flow restriction with funnel catheter can play in enhancing endovascular thrombectomy and potentially improving outcomes for stroke patients,” commented Dr. Majidi in Anaconda’s press release.
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