REDEFINING HYDROCEPHALUS TREATMENT TO IMPROVE LIVES

Cranial Devices, Inc. is an early-stage neurosurgical device company developing HydroFix™, a breakthrough, physiologic shunt system that will significantly reduce shunt failure rates and improve the quality of life for hydrocephalus patients around the world.

HYDROCEPHALUS

Hydrocephalus is a chronic neurological condition caused by an abnormal accumulation of cerebrospinal fluid (CSF) within the brain, creating harmful pressure on the brain. Hydrocephalus can be fatal if not treated. Symptoms include headache, vomiting, impaired vision, cognitive difficulties, loss of coordination, and incontinence.

Hydrocephalus impacts all ages and has many underlying causes and forms, most commonly occurring in children and the elderly.

SHUNT FAILURE

Today’s most prevalent treatment for hydrocephalus is the implantation of a ventriculoperitoneal (VP) shunt that drains CSF from the ventricles inside the brain through a long catheter that is tunneled under the skin to the peritoneal cavity within the abdomen. These shunts require an adjustable pressure valve that controls the flow of excess CSF out of the brain.

VP shunts frequently stop working for a variety of reasons, including:

Infection, migration, breakage and malfunction.
Underdrainage – due to clogging or improper valve pressure setting
Overdrainage – due to siphoning of the CSF when the patient goes from lying down to standing up.

The very poor performance of current shunt systems forces patients to face a lifetime of ongoing symptoms, reinterventions, and reoperations.

HYDROFIX™ VENTRICULOSINUS (VS) SHUNT

Cranial Devices, Inc. has developed HydroFix, a breakthrough hydrocephalus shunt technology that eliminates the common failure modes of existing shunt systems by returning excess CSF from the ventricle directly to the superior sagittal sinus - the normal, physiological pathway for return of CSF to the venous system.

HydroFix’s unique design relies on the constant difference between higher ventricular pressure and lower sinus pressure to govern the rate of CSF drainage. Body position does not impact the relative pressure difference because the CSF source and drainage locations are both inside the rigid cranium.