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# FDA Clears Alcyone Lifesciences Alivio System
- URL: https://www.fdaweb.com/fda-clears-alcyone-lifesciences-alivio-system/
- Published: 2017-11-15T12:00:00.000Z
- Updated: 2026-09-14T23:01:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140142

FDA has cleared an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus. This comes on the heels of Alcyone receiving the EU CE Mark last month. The device is intended to provide clinicians with the option of non-invasive retrograde flushing of the ventricular catheter, to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid (CSF) flow in a non-flowing shunt. Hydrocephalus is a condition in which an excess of CSF accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation. CSF shunts are implantable devices inserted by neurosurgeons to treat hydrocephalus. “Although shunts facilitate treatment for many cases, according to The Hydrocephalus Association at least 50% of patients implanted with shunts suffer from shunt failures and blockages within two years, requiring repeated revision surgeries,” the company says.