FDA clears Medtronic's hydrocephalus valve:
This article was originally published in Clinica
Executive Summary
Medtronic Neurosurgery has launched in the US its implantable Strata valve for shunting, or draining, excess cerebrospinal fluid from the brain of people with hydrocephalus, after gaining FDA 510(k) clearance for the device. Unlike traditional valves, the new device enables clinicians to adjust its five pressure settings noninvasively and without the need for X-ray verification as the patient's condition changes, says the company. These features could also reduce the frequency of valve replacements. The Strata valve also protects against excess drainage of cerebrospinal fluid, a complication that can lead to tissue tears or bleeding in the brain. Around 160,000 people worldwide are estimated to receive a hydrocephalus shunt annually.