FDA approves Medtronic’s Specify SureScan MRI-safe neurostim leads

Medtronic (NYSE:MDT) said today that the FDA approved its MRI-safe Specify SureScan spinal cord stimulation leads for treating chronic pain.

The Fridley, Minn.-based medtech titan said the approval means it is the sole company to offer a full U.S. suite of SCS devices that are safe for full-body MRI scans. The Specify SureScan leads are due to hit the market later this month, Medtronic said.

“The use of MRI as a diagnostic tool has grown significantly. Medtronic appreciates the opportunity to offer physicians the only full portfolio of SCS systems that allow patient access to full-body MRIs, facilitating optimal patient care and timely interventions,” vice president Julie Foster said in prepared remarks. “Medtronic remains committed to the advancement of spinal cord stimulation therapy overall and continues to ensure greater access to MRIs across many of our implanted Medtronic systems, such as pacemakers, ICDs and deep-brain stimulation systems.”

“All patients with a spinal cord stimulation system should have the ability to be offered the same imaging options as those without one,” added Dr. Steven Falowski, of the St. Luke’s University Health Network in Bethlehem, Pa. “Now more than ever, patients and other healthcare providers are concerned about access to MRI when considering an implantable device. This approval means I can offer a neurostimulation system that helps manage my patients’ pain and gives them access to the diagnostic benefits of MRI.”

Earlier this week Medtronic reported a solid 3rd quarter for 2016, with profits up 12.1% to $ $1.1 billion,or 77¢ per share, on sales growth of more than 60% to $6.9 billion for the 3 months ended Jan. 29.  Adjusted to exclude 1-time items, profits were $1.5 billion, or $1.17 per adjusted share, trouncing the Wall Street consensus for adjusted EPS of $1.06.

MDT shares closed at $74.59 apiece yesterday, down -3.6%  since their $77.39 close Feb. 29, the day before the earnings announcement.

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