Anaconda Biomed has announced the enrolment and treatment of the first US patient by Shahram Majidi (Mount Sinai, New York, USA) in its ATHENA clinical trial.
ATHENA is a global, randomised, 327-patient pivotal study evaluating the safety and effectiveness of Anaconda’s proprietary Ana funnel catheter—a device 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 suffering from acute ischaemic stroke caused by a large vessel occlusion.
“We have long recognised 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 a funnel catheter can play in enhancing endovascular thrombectomy and potentially improving outcomes for stroke patients,” Majidi commented.
Anaconda’s funnel catheter features the largest capture diameter currently available for neuroendovascular thrombectomy, as stated in a recent company press release.
Feasibility studies conducted with the device have demonstrated high rates of reperfusion and first-pass success, along with a strong safety profile, with these data being instrumental in supporting the company’s investigational device exemption (IDE) submission for ATHENA—which gained approval from the US Food and Drug Administration (FDA) in September 2024.
“The ATHENA clinical trial marks the next important step in advancing our funnel catheter technology for ischaemic stroke and builds on the promising preliminary efficacy results observed during our earlier ANAIS study,” said Trent Reutiman, chief executive officer (CEO) of Anaconda. “We are pleased to now be enrolling this vital study in the USA while also achieving a fast start internationally.”
As noted in its recent release, Anaconda intends to complete enrolment in the ATHENA IDE study in the first half of 2026.
