Anaconda Biomed
Anaconda Biomed S.L., a medical technology company developing next-generation thrombectomy systems, has announced that it has received conditional IDE approval from the U.S. Food and Drug Administration to begin the ATHENA study of its ANA Funnel Catheter. The prospective, randomised, dual-arm, multi-center study will assess the safety and effectiveness of mechanical thrombectomy using the ANA5 Advanced Neurovascular Access (ANA Funnel Catheter) in combination with a stent retriever.
“The neurointerventional community is eager to assess this innovative technology, which is designed to enhance the efficiency of mechanical thrombectomy,” said Dr. Adnan Siddiqui, coordinating investigator of the ATHENA study. “Even a small difference in the revascularisation success after one pass can have a profound impact on the clinical outcomes of people with ischemic stroke.”
Studies have shown that flow arrest during mechanical thrombectomy can improve revascularisation rates and clinical outcomes at three months. However, the approach has been underutilised to date due to the limitations of current devices. Anaconda Biomed’s ANA Funnel Catheter is uniquely designed to facilitate flow arrest during clot retrieval.
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Upon Institutional Review Board (IRB) approval, the ATHENA study of the ANA Funnel Catheter will be conducted at up to 40 U.S. and international centers enrolling patients experiencing acute ischemic stroke and treated within 24 hours of symptom onset. The study will report acute reperfusion success after a single thrombectomy pass with three of the most commonly used stent retrievers, and on procedural safety between study arms.
“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.”
ANA Funnel Catheter is a catheter designed to assist in neurovascular procedures by facilitating the delivery of other intravascular devices (i.e., stent retriever devices and catheters). The device consists of a radiopaque Nitinol braid covered with a silicone coating to enable local flow arrest. The catheter is currently an investigational device and is not available for sale in the United States or the European Union.
