The US Food and Drug Administration (FDA) has granted clearance for Alcyone Lifesciences' Alcyone MEMS Cannula (AMC), a neuro-ventricular cannula.
The AMC is a dual-lumen, MRI-compatible injection and aspiration cannula, designed for use in the brain.
The company said the AMC is not intended for implant and was developed for single patient use only.
Alcyone Lifesciences founder PJ Anand said: "The neuroscience community is pioneering new therapeutic agents including gene therapy, antibody and oncolytic biologic therapy that hold great promise in treating chronic CNS disorders, but unfortunately they have lacked a clinically effective technology for precise CNS delivery direct to a neurological target and for optimal bio-distribution.
"Given that the very potential of these new agents is dependent on optimal bio-distribution, it is our hope that the AMC will offer a solution for this critical unmet clinical need and further open the gates to novel therapeutic options for patients."
Developed using the company's microelectromechanical system (MEMS) platform, the AMC can be used with any existing commercial imaging and stereotactic system.
Alcyone director of Product Development Deep Singh said: "Neurosurgeons can select a target, navigate the AMC precisely to the target, and observe in real-time the precision delivery of the therapeutic agent, all under intra-procedural MRI guidance."
Apart from the MEMS tip which has dual micro-channels, the AMC features a patented distal end design that helps prevent reflux or back flow along the cannula shaft, which can be a significant drawback with current devices.
Image: Alcyone MEMS Cannula. Photo: courtesy of Business Wire / Alcyone Lifesciences Inc.