Anaconda’s ANA Funnel Catheter to Be Evaluated in ATHENA Study

July 17, 2024—Anaconda Biomed SL, a developer of next-generation thrombectomy systems, announced that it received conditional investigational device exemption approval from the FDA to begin the ATHENA study of its ANA5 advanced neurovascular access funnel catheter, which is designed to facilitate flow arrest during clot retrieval.

According to the company, the prospective, randomized, dual-arm, multicenter study will assess the safety and effectiveness of mechanical thrombectomy using the ANA funnel catheter in combination with a stent retriever.

Anaconda Biomed stated that upon institutional review board approval, the ATHENA study of the ANA funnel catheter will be conducted at up to 40 United States 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 neurointerventional community is eager to assess this innovative technology, which is designed to enhance the efficiency of mechanical thrombectomy,” commented Adnan Siddiqui, MD, coordinating investigator of ATHENA, in the company’s press release. “Even a small difference in the revascularization success after one pass can have a profound impact on the clinical outcomes of people with ischemic stroke.”

Anaconda Biomed’s ANA funnel catheter is designed to assist in neurovascular procedures by facilitating the delivery of other intravascular devices (ie, 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 European Union, advised the company.