Alcyone Lifesciences wins FDA nod for Alivio hydrocephalus shunt flusher

Alcyone Lifesciences said yesterday it won FDA 510(k) clearance for its Alivio ventricular catheter and flusher system designed for treating hydrocephalus. The newly cleared Alivio device is designed for the non-invasive retrograde flushing of the ventricular catheter to unblock occluded inlet holes or open a relief membrane to restore or increase cerebrospinal fluid flow in non-flowing shunts, the Lowell, Mass.-based company said. “For the first time in over half a century there has been a game changing improvement in the field of hydrocephalus treatment.  Ventricular shunting can help save lives and improve the quality of life that otherwise most patients with hydrocephalus would never experience.  However, shunt failures can be abrupt, without warning, carry significant morbidity, and be life-threatening. The implantation of Alcyone’s new Alivio Shunt System will enable neurosurgeons with the ability to provide emergency treatment during shunt malfunctions, delivered completely non-invasively, preventing neurological decline and allowing time for patients to reach definitive neurosurgical care,” Dr. Ramin Eskandari of the Medical University of South Carolina said in a prepared release. Alcyone said the device is intended to offer an alternative to revision surgeries often required to prevent shunt failures in patients with hydrocephalus. “Patients and families dealing with hydrocephalus deserve a better quality of life and It is our hope that the...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Neurological Regulatory/Compliance Alcyone Lifesciences Source Type: news