Medtronic wins FDA clearance for StrataMR valves

Medtronic (NYSE:MDT) today said it won FDA clearance for its StrataMR valves and shunts for patients with hydrocephalus and cerebrospinal fluid conditions.

The clearance allows the valves and shunts to be used during MRI scans at their performance level setting at up to 3.0 Tesla, Fridley, Minn.-based Medtronic said. StrataMR is slated to be available “in the coming months,” the company said.

“Patients with hydrocephalus and CSF disorders often require MRI,” CSF management director Tom Poss said in prepared remarks. “The use of MRI has become a diagnostic standard of care, allowing physicians to detect a wide range of health conditions. And our StrataMR technology will offer healthcare providers a level of confidence in the shunt’s performance should an MRI become necessary.”

“I see many implications for the use of the new StrataMR, especially with patients who need to have their valves re-checked after MR imaging,” added Dr. Marion Walker of the University of Utah. “Also, this technology will benefit those patients who are concerned about their exposure to strong magnets. This new technology may cut down on some of the insecurities these patients may feel.”

“The StrataMR system builds on the reliability and convenience of Medtronic’s Strata family of innovative therapies for the CSF community,” neurosurgery general manager Scott Hutton said in a press release. “Innovation continues to differentiate Medtronic. StrataMR now joins a growing number of Medtronic therapies that allow greater access to MRIs, including DBS systems, pacemakers, and ICDs.”

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