July 21, 2016
July 21, 2015
*The Alcyone MEMS Cannula (AMC™) System, a neuro-ventricular cannula, has US Food and Drug Administration (FDA) 510(k) clearance, Health Canada Licensing, and CE Marking. It is indicated for use in the U.S. and Canada for the injection of Cytarabine or the removal of cerebrospinal fluid from the ventricles of the brain during an intracranial procedure, and approved in Europe for injection or removal of substances from the brain and/or ventricles of the brain during intracranial procedures. The AMC is a dual-lumen, MR-compatible injection and aspiration cannula and can be used with existing commercial imaging and stereotactic systems. The AMC is not intended for implant, and it is intended for single patient use only.
** The Pulsar System is not yet available for commercial use and has not yet been cleared by the FDA.
*** The ReFlow™ Ventricular System is not available for commercial use. The ReFlow™ Ventricular System is pending 510(k) clearance from the U.S. Food and Drug Administration, and CE Marking.