Medtronic has received approval from the US Food and Drug Administration (FDA) for its new Specify SureScan magnetic resonance imaging (MRI) surgical leads to treat chronic pain.
The approval will allow the company to use surgical leads as part of its 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.
Medtronic restorative therapies group’s 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.
MRI scans enable physicians to detect a 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.
Last month, Medtronic received FDA approval for MRI conditional cardiac resynchronization therapy defibrillators (CRT-Ds) to treat heart failure.
The company also won 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.