Device manufacturer Medtronic announced U.S. Food and Drug Administration (FDA) clearance of its StrataMR line of valves and shunts designed for conditional use in MRI environments.
The clearance is an addition to Medtronic's suite of Strata adjustable valve systems used in the treatment of patients with hydrocephalus and cerebrospinal fluid (CSF) disorders. The StrataMR system is intended to maintain its performance level setting during MRI exposure when scanned in accordance with labeling, the firm said.
StrataMR is available in a variety of sizes and configurations for hydrocephalus management. It contains a magnet inside the valve mechanism that allows the neurosurgeon to adjust the performance level setting as needed in his or her office. Neurosurgeons should still check performance levels after MRI exposure, but the StrataMR system is designed to resist setting changes in an MRI field up to 3 tesla, Medtronic said.
The StrataMR system will be available to physicians and their patients in the coming months.
