ReFlow™ System Mini is discovered for the treatment of CSF disorders which requires shunting such as hydrocephalus.
The new ReFlow System Mini can be used not only with newly implanted, but can also be applicable for revised shunt system in any size patient. Moreover, the system will reduce the amount of emergent hospitalizations, it also lessens the patient and healthcare system costs, increases overall clinical outcomes and quality of life for patients living with hydrocephalus.
The ReFlow System Mini is used to treat wide range of hydrocephalus population including young women with pseudo tumor cerebri, non-communicating hydrocephalus in infants and older patients with communicating idiopathic Normal Pressure Hydrocephalus (iNPH).
CSF disorders are the most life-threatening disease affecting not less than 1 million U.S. patients. Half of the intracranial shunts fail in the first two years. One of the main reasons for the failure of intracranial shunts is due to blockages which damage the CSF flow resulting in emergency revision surgery.
U.S. Food and Drug Administration (FDA)has granted Breakthrough Device Designation for ReFlow™ System Mini designed for the treatment of CSF disorders.