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March 3, 2016

FDA approves Medtronic’s new Specify SureScan MRI surgical leads

The US Food and Drug Administration (FDA) has granted approval for Irish medical technology firm Medtronic's new Specify SureScan magnetic resonance imaging (MRI) surgical leads.

Medtronic WHQ

The US Food and Drug Administration (FDA) has granted approval for Irish medical technology firm Medtronic’s new Specify SureScan magnetic resonance imaging (MRI) surgical leads.

The approval allows surgical leads to be used as part of the company’s implanted neurostimulation systems for the treatment of chronic pain.

In 2013, the company launched the only implantable neurostimulation systems to treat chronic and intractable back and/or limb pain, which are FDA approved for full-body MRI scans under specified conditions.

"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." 

With the approval of SpecifySureScan MRI surgical leads, the company is now claimed to have a full portfolio of spinal cord stimulation (SCS) systems FDA approved for full-body MRI.

St Luke’s University Health Network neurosurgeon Dr Steven Falowski said: "All patients with a spinal cord stimulation system should have the ability to be offered the same imaging options as those without one.

"Now more than ever, patients and other health care 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."

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MRI scans allow physicians to detect a wide range of health conditions through viewing highly detailed images of internal organs, blood vessels, muscles, joints, tumors, areas of infection and other areas of the body by using strong magnetic fields and radio frequency pulses.

These will help to create images of structures inside the body.

Medtronic restorative therapies group pain therapies business general manager and vice-president Julie Foster said: "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.

"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."

The company will start selling the new Specify SureScan MRI leads for physicians and their patients later this month.

In February, the company received FDA approval MRI conditional cardiac resynchronisation therapy defibrillators (CRT-Ds) to treat heart failure.

The firm obtained FDA approval for Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems to perform MRI scans on any part of the body without positioning restrictions.


Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.

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