BARCELONA, Spain & MARIN, Calif.--(BUSINESS WIRE)--#clinicaltrials--Anaconda Biomed, S.L., a medical technology company developing next generation neurothrombectomy devices, today announced the enrollment and treatment of the first U.S. patient in its ATHENA clinical trial by Shahram Majidi, MD, Associate Professor of Neurosurgery, Neurology, and Radiology at Icahn School of Medicine at Mount Sinai, New York.
ATHENA is a global, randomized 327-patient pivotal study evaluating the safety and effectiveness of Anaconda’s proprietary ANA Funnel Catheter™. The device 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 suffering from large vessel occlusion acute ischemic stroke.
Globally, stroke ranks among the top three leading causes of death and the primary cause of serious long-term disability. One in four people over age 25 will have a stroke in their lifetime, with about 87 percent of cases classified as ischemic events caused by emboli or thrombotic occlusions in the neurovasculature. Due to the aging of the population and the strong association between stroke risk and age, the number of people experiencing stroke is expected to rise significantly, with a 34 percent increase in events projected by 2035.
Anaconda’s funnel catheter features the largest capture diameter currently available for neuroendovascular thrombectomy. Feasibility studies conducted with the device demonstrated high rates of reperfusion and first-pass success, along with a strong safety profile – data that was instrumental in supporting the company’s Investigational Device Exemption (IDE) submission. 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.
“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,” said Dr. Majidi.
Trent Reutiman, chief executive officer of Anaconda Biomed, added, “The ATHENA clinical trial marks the next important step in advancing our funnel catheter technology for ischemic stroke and builds on the promising preliminary efficacy results observed during our earlier ANAIS Study. We are pleased to now be enrolling this vital study in the U.S. while also achieving a fast start internationally.”
Anaconda Biomed intends to complete enrollment in the ATHENA IDE study in the first half of 2026.
About the ANA Funnel Catheter Device
The ANA5™ is a funnel catheter designed to assist in neurovascular procedures by facilitating the delivery of intravascular devices such as stent retrievers and microcatheters. It features a radiopaque, self-expanding funnel covered with a continuous sealing coating that enables temporary local flow restriction upon deployment.
During acute ischemic stroke thrombectomy procedures, especially in combination with stent retrievers, the funnel catheter may enhance clot removal due to its large lumen—matching the diameter of the target artery.
About Anaconda Biomed, S.L.
Anaconda Biomed, S.L. is a company focused on the clinical and commercial development of its proprietary funnel catheter technology, for better enabling mechanical thrombectomy in acute ischemic stroke. For more information, please visit https://anaconda.bio and follow the company on LinkedIn.
Contacts
Corporate Contact:
Trent Reutiman
Chief Executive Officer
t.reutiman@anaconda.bio
Media Contact:
Joe Duraes
Pazanga Health Communications
jduraes@pazangahealth.com
917-687-6419
