George Mandybur, MD, above, performed the surgical procedure Dec. 28, 2011 at UC Health / University Hospital on a female patient who was suffering from reflex sympathetic dystrophy (RSD), also known as complex regional pain syndrome (CRPS)

January 17, 2012
FOR IMMEDIATE RELEASE

CONTACT: Tom Rosenberger, APR
Communications Department
513-569-5260

Cindy Starr, MSJ
Communications Department
513-569-5236

Mayfield Clinic neurosurgeon implants first Medtronic sensor stimulator for pain relief Ohio & Greater Cincinnati region

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New orientation technology adjusts spinal cord stimulation as patient changes positions

CINCINNATI – George Mandybur, MD, a neurosurgeon with the Mayfield Clinic, has become the first physician in both Ohio and the Greater Cincinnati-Northern Kentucky region to implant a new spinal cord stimulator for treating chronic pain that incorporates an accelerometer similar to those used in smart phones and gaming technology. Dr. Mandybur performed the surgical procedure Dec. 28, 2011 at The Christ Hospital Spine Surgery Center on a patient who was suffering from reflex sympathetic dystrophy (RSD), also known as complex regional pain syndrome (CRPS).

The new AdaptiveStim™ with RestoreSensor™ neurostimulation system, marketed by Medtronic, Inc., was approved by the U.S. Food & Drug Administration in November 2011. It is the first chronic pain treatment that harnesses motion sensor technology to automatically adapt stimulation levels to the needs of people with chronic pain in the back and/or leg.

Spinal cord stimulators, implantable devices that interrupt pain signals and prevent them from reaching the brain, have been used to treat chronic pain since the 1970s. The RestoreSensor™’s novelty is that it frees patients from continually making manual adjustments to stimulation levels as they move about during the day.

The RestoreSensor™ also will be implanted in patients by four additional Mayfield Clinic neurosurgeons: Arthur Arand, MD, who practices in Fairfield, Middletown, and West Chester, Ohio; Steven Bailey, MD, who practices in Northern Kentucky; Brad Curt, MD, who practices in West Chester and Middletown, Ohio; and Tann Nichols, MD, who practices in northern and northeastern Kentucky.

"The advantage of the new sensor stimulator over previous stimulators is that it will ‘learn’ how to adapt to the individual’s positioning," explains Dr. Mandybur, an associate professor of neurosurgery at the University of Cincinnati College of Medicine. "So as the patient changes positions, mainly from sitting to standing to lying down, the multi-axis system understands the patient’s position through an advanced accelerometer type of technology."

Reflex sympathetic dystrophy, a chronic, painful, and progressive neurological condition, typically develops after an injury, such as a broken leg or even a sprained ankle. It can also develop after surgery, and in some cases no cause is ever established. The first patient treated by Dr. Mandybur suffered a sports-related injury to her foot that developed into reflex sympathetic dystrophy.

The RestoreSensor™, in addition to being used to treat RSD, will be used to treat spinal disorders that result in in chronic pain.

Candidates for spinal cord stimulators are those who have not gained relief from conventional treatment or physical therapy. A candidate for pain stimulation undergoes a spinal cord stimulator trial, which involves: 1) the careful insertion of electrodes through the skin and into the epidural space, the outermost portion of the spinal canal; and 2) the placement of the pulse generator and battery pack in a temporary position on the patient’s belt or clothing, like a pager.

If the stimulator effectively reduces pain, the electrodes are then surgically anchored and the battery pack and generator surgically implanted under the skin in the abdominal area or buttock, so that all wiring is internalized. Because the battery pack itself shifts while the wound is healing, the sensor stimulator is not programmed until a month after surgery.

Marc Orlando, MD, a physiatrist and rehabilitation specialist for TriHealth, performed stimulator testing on the first tri-state recipient of the RestoreSensor™.

"Implanting the RestoreSensor™ is exactly the same as implanting its technological predecessors," says Dr. Mandybur, who implanted more than 50 spinal cord stimulators in patients in 2011. "There is no change in the surgical techniques, and there is no increased risk to the patient."

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The Mayfield Clinic is recognized as one of the nation's leading physician organizations for clinical care, education, and research of the spine and brain. Supported by 21 neurosurgeons, six neurointensivists, an interventional radiologist, six physical medicine & rehabilitation specialists, and a pain specialist, the Clinic treats 25,000 patients from 35 states and 13 countries in a typical year. Mayfield's physicians have pioneered surgical procedures and instrumentation that have revolutionized the medical art of neurosurgery for brain tumors and neurovascular diseases and disorders.