Barcelona–Â ANACONDA Biomed, a Spanish medical technology company specializing in stroke intervention devices, has received CE Mark certification for its ANA5 Funnel Catheter, a next-generation tool designed to improve mechanical thrombectomy in patients with acute ischemic stroke.
The CE Mark signifies that the ANA5 meets the European Union’s rigorous standards for health, safety, and environmental protection, opening the door for its commercialization across Europe.
The catheter is engineered with a vessel-matching diameter funnel that enhances clot capture, while enabling antegrade flow arrest and the potential for flow reversal—key features intended to improve the effectiveness of aspiration-assisted clot retrieval. Its proprietary design aims to increase first-pass success rates and overall reperfusion during stroke intervention.
“Receiving CE Mark approval is a pivotal achievement for ANACONDA Biomed that advances our mission to innovate in the interventional management of acute ischemic stroke,” said CEO Trent Reutiman. “We now have the capability of making ANA5 available to clinicians across Europe, bringing this innovative technology to broader stroke application.”
The regulatory approval is supported by robust data, including preclinical trials and clinical findings from the ANAIS study, which demonstrated high reperfusion and strong first-pass efficacy. Ongoing evaluation in the ATHENA trial, a prospective, multicenter randomized study, aims to provide further evidence for future U.S. regulatory approval.
Dr. Marc Ribo, co-founder of ANACONDA Biomed, highlighted the significance of the milestone: “This is more than a regulatory achievement; it’s the moment where innovation becomes impact. Years of research and persistence have brought us to this point, and we’re now preparing to collect valuable real-world data from stroke centers across Europe.”
The CE Mark approval puts ANACONDA Biomed in a strong position to scale its impact on stroke treatment in Europe while continuing efforts toward U.S. market entry.
