Biomedical device company Alcyone Lifesciences Inc revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) clearance for the Alivio Ventricular Catheter & Flusher System (Alivio System) for the treatment of hydrocephalus.

Hydrocephalus, a condition in which an excess of cerebrospinal fluid (CSF) accumulates within the ventricles and increases pressure in the brain, resulting in a life-threatening situation.

The company added the US FDA approval follows last month's EU CE Mark. It will now commercialise the Alivio System in the US and Europe through qualified clinicians, providing patients 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.

Additionally, the company's Alivio System is comprised of a Flusher and Ventricular Catheter (VC) with a unique relief membrane. The system, in conjunction with any CSF shunt flow regulating valve and drainage catheter, is designed to address one of the two most common problems with CSF shunts -- obstructions of the ventricular catheter. Also, the retrograde flushing using flow regulating valves and invasive shunt taps have been employed by some neurosurgeons in attempt to unblock ventricular catheters. The CSF shunts are implantable devices inserted by neurosurgeons to treat Hydrocephalus.

This fully implantable and non-invasive treatment concept designed to consistently unblock an occluded VC is based on from results of a prior clinical evaluation performed at Boston Children's Hospital (BCH), where the flushing concept was studied on VCs undergoing revision due to occlusions and then also flushed successfully to improve flow using the Alivio Flusher.

In conjunction, the company aims to educate Hydrocephalus patients and families about the system, treatment options and other conditions associated with the disease through its newly launched patient-oriented website, http://www.ReflowVentCath.com.