Alycone Lifesciences’ MEMS Cannula, a neuro-ventricular device for central nervous system disorders, has won FDA 510(k) clearance, the Lowell, Mass., devicemaker announced Tuesday.
The AMC, which takes advantage of the company’s microelectromechanical system platform, is a dual-lumen, MRI-compatible injection and aspiration cannula meant for single use in the brain. The system features a unique patented distal end designed to prevent reflux or back flow along the cannula shaft.
Previously, physicians have lacked the technology to effectively deliver CNS therapies to a neurological target, says PJ Anand, founder and CEO. He hopes the AMC will meet that need by providing optimal biodistribution, which is crucial for neurotherapy efficacy.
The company has three exclusive collaborations with biopharmaceutical firms and plans to move into Phase II trials with one of them soon, PJ Anand told Device Daily Tuesday.
The devicemaker expects CE Mark approval in the next few weeks. — Jason Scott