Anaconda Biomed Gets FDA IDE Nod for ATHENA Study

Anaconda Biomed has obtained conditional investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to start the ATHENA study of its ANA Funnel Catheter.

The study will assess the ANA Funnel Catheter’s safety and effectiveness of mechanical thrombectomy in combination with a stent retriever. Once approved by the Institutional Review Board (IRB), the study will be hosted at up to 40 U.S. and international centers, enrolling patients with acute ischemic stroke and treated within a day of symptom onset.

The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly used stent retrievers, as well as on procedural safety between study arms.

The ANA (Advanced Neurovascular Access) Funnel Catheter assists in neurovascular procedures by assisting delivery of stent retrievers and catheters. It’s comprised of a radiopaque Nitinol braid with a silicone coating to allow local flow arrest.

“The IDE approval marks an exciting milestone in our company’s mission to deliver new, safe and effective solutions that can meaningfully improve the treatment of stroke,” said Anaconda Biomed CEO Francois Salmon. “We believe the ANA Funnel Catheter has the potential to transform the treatment of acute ischemic stroke, improving neurological outcomes and benefiting countless patients.”