Biomedical company Anaconda Biomed secures CE Mark for their ANA5 Funnel Catheter
The medical technology company Anaconda Biomed has received CE Mark certification for its innovative ANA5 Funnel Catheter. This approval, supported by a comprehensive body of evidence, permits commercial use across the European Union. The CE Mark approval is more than a regulatory milestone; it's the moment where innovation becomes impact, according to Dr. Marc Ribo, Co-Founder of Anaconda Biomed.
The ANA5 Funnel Catheter is engineered to optimize mechanical thrombectomy by maximizing clot capture. This device enables antegrade flow arrest and offers the potential for flow reversal, promoting improved clot capture and removal through its unique proprietary geometry.
The CE Mark approval is followed by the enrolment of the first U.S. patient in the ATHENA trial, an ongoing, prospective, multicenter, randomized clinical study. The ATHENA trial is a pivotal, global randomized controlled trial, approved by the FDA, designed to further validate the clinical effectiveness of the ANA5 device. It aims to systematically evaluate the impact of proximal flow arrest on reperfusion success in ischemic stroke treatment, supporting future regulatory submissions and commercialization in the United States.
The trial evaluates both the safety and efficacy of the ANA5 Funnel Catheter. Enrollment for the trial began in or before mid-2025. The trial's outcomes are crucial for regulatory approval and commercial availability of ANA5 in the U.S. market, where the device remains investigational and not yet for sale.
Trent Reutiman, Chief Executive Officer of Anaconda Biomed, stated that the CE Mark approval advances the company's mission to innovate in the interventional management of acute ischemic stroke. Dr. Ribo also commented that the CE Mark approval is deeply meaningful and represents the culmination of years of research, iteration, and belief in an idea.
The ANAIS study, which demonstrated high reperfusion and first-pass success rates, is part of the evidence supporting the CE Mark approval. The evidence also includes preclinical bench and animal studies. The ATHENA trial is actively ongoing to confirm and expand the clinical evidence supporting the ANA5 catheter's use, particularly for the U.S. regulatory pathway.
In summary, the ATHENA trial is a significant step forward in the journey of Anaconda Biomed's ANA5 Funnel Catheter. The device is commercially available in Europe, while in the U.S., it remains investigational, pending ATHENA trial outcomes. The company continues to gear up to capture real-world data by collecting more invaluable insight into how ANA5 performs across diverse stroke centres and clinical realities.
The ANA5 Funnel Catheter, with its potential to revolutionize medical-conditions like ischemic stroke, is employed in health-and-wellness therapies and treatments. The CE Mark approval signifies the beginning of commercial use in the European Union, and the ATHENA trial in the United States will further validate its clinical effectiveness, leading to potential regulatory submissions and commercialization.
