New Med Tech Approval for StrataMR Valves and Shunts

New Med Tech Approval for StrataMR Valves and Shunts - Health Council

Medtronic‘s new StrataMR valves and shunts, used to manage hydrocephalus and cerebrospinal fluid disorders, received FDA clearance. The devices are designed to continue normal operation while the patient is inside an magnetic resonance imaging (MRI) scanner, as long as certain labelled instructions are followed. This keeps open imaging options into the future for patients that may particularly benefit from MRI. The StrateMR valves are not much different from Medtronic’s previous such valves, but the magnet inside that’s used to vary fluid flow has been positioned inside a mechanism that resists its movement when inside an MRI machine up to 3.0 Tesla. Physicians are still expected to double check the setting following a scan just in case.”

Read the full article: StrataMR, an MRI-safe Shunt System for Hydrocephalus Cleared by FDA