Medtronic cleared to market MRI-compatible brain shunt
The FDA has given Medtronic the go-ahead to market an MRI-compatible product in their line of valves and shunts for patients with hydrocephalus and cerebrospinal fluid disorders, many of whom regularly require MR scans.
The company announced the approval May 2, stating that the new StrataMR system is similar to other offerings in its Strata product family but with the added capability of resisting setting changes in an MRI field of up to 3.0 Tesla.
The announcement includes a comment from Marion Walker, MD, a professor of neurosurgery at the University of Utah, who says he sees “many implications for the use of the StrataMR, especially with patients who need to have their valves re-checked after MR imaging.”
The company says the new product will be available in the coming months.