Anaconda Biomed has announced that it has received conditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the ATHENA study of its ANA funnel catheter. This prospective, randomised, dual-arm, multicentre study will assess the safety and effectiveness of mechanical thrombectomy using the catheter device 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 Adnan Siddiqui (Jacobs Institute/University at Buffalo, Buffalo, USA), 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 ischaemic stroke.”
Studies have shown that flow arrest during mechanical thrombectomy can improve revascularisation rates and clinical outcomes at three months, according to a recent Anaconda press release. However, the release continues, the approach has been underutilised to date due to the limitations of current devices. Anaconda’s ANA funnel catheter is uniquely designed to facilitate flow arrest during clot retrieval.
Upon institutional review board (IRB) approval, the ATHENA study of the ANA funnel catheter will be conducted at up to 40 US and international centres enrolling patients experiencing acute ischaemic 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 chief executive officer Francois Salmon. “We believe the ANA funnel catheter has the potential to transform the treatment of acute ischaemic stroke, improving neurological outcomes and benefitting countless patients.”
