Published on December 12th, 2016
MD News: Dr. Falowski Implants MRI-Friendly Device
(BPT) – Do-it-yourself projects can be fraught with unexpected challenges, but for Joseph Getz, a bathroom remodel aggravated existing back issues and caused unbearable pain. I’m of a generation that works through the pain, but the truth is that my quality of life really took a nose dive, said Getz.
After living in pain and trying to manage it through physical therapy, pain medicine and spinal injections, Getz, a Nazareth, Pennsylvania resident, opted to get a spinal cord stimulation (SCS) system to treat his pain. An SCS system includes a medical device implanted under the skin that sends mild electrical pulses to an area near the spine via thin wires (called leads). These pulses disrupt the pain signals traveling between the spinal cord and the brain, offering people effective pain relief and improved function and health-related quality of life.1 However, SCS results vary, and not every individual will receive the same benefits or experience the same complications.
With a history of chronic back issues and a number of other health concerns, Getz was no stranger to medical procedures or needing MRI imaging. You never know what’s going to happen. I snapped my Achilles tendon walking and immediately needed an MRI and emergency surgery, said Getz. That experience on top of my other health issues made it really important for me to get an SCS system that didn’t limit my ability to access MRI scans in the future.
MRI scans allow physicians to detect a wide range of health conditions by viewing highly detailed images of internal organs, blood vessels, muscles, joints, tumors and areas of infection. In the United States, scans have nearly doubled in the past decade, with 32 million scans more than one MRI per second — performed in 2011.2 People with chronic pain have a high likelihood of needing MRIs and access to full-body MRI scans has been a critical unmet need with SCS therapy. In fact, eighty-two percent of people implanted with a spinal cord stimulator are expected to need an MRI within five years of receiving their implant.3
Earlier this year, the FDA approved Specify™ SureScan™ MRI surgical leads, which are manufactured by medical-device leader Medtronic and indicated for use as part of Medtronic SCS systems for chronic pain. In 2013, Medtronic introduced the first implantable SCS systems for use in the treatment of chronic, intractable back and/or limb pain that are FDA approved for full-body Magnetic Resonance Imaging (MRI) scans under specified conditions, and the Specify™ SureScan™ MRI approval now establishes Medtronic as the only company to offer a complete portfolio of implanted SCS systems for chronic pain designed for access to full-body MRI.
This expands access to MRIs and this important diagnostic standard of care, which can help facilitate optimal care and timely interventions.
Mr. Getz has a history of health concerns unrelated to his back problems requiring follow up imaging, and he expressed concern about the ability to obtain MRIs with his new device, said Steven Falowski, M.D., neurosurgeon at St. Luke’s University Health Network in Bethlehem, Pennsylvania and one of the first to implant the Medtronic MR conditional system. Having this technology available to him allows him to obtain the significant benefits of pain relief without limiting his need for follow up imaging.
The inability to undergo full-body MRI presents potential risks, including delayed or inaccurate identification of critical health conditions that could progress if they remain undiagnosed. Some individuals with an SCS system have traditionally been limited when receiving MRI scans, as the scans produce electromagnetic fields that can damage the device or cause injury to the patient. These patients have the option of undergoing computerized tomography (CT) scans, which work well for imaging bones and other hard materials, but are less effective in examining soft tissue.
All patients with a spinal cord stimulation system should have the ability to be offered the same imaging options as those without one, notes Dr. Falowski. Today more than ever, patients and health care providers are concerned about access to MRI when considering an implantable device. Now I can always offer a neurostimulation system that helps manage my patients pain and gives them access to the diagnostic benefits of MRI.
I’m grateful that I no longer have to live in pain, but the best thing is that I can pick up my grandchildren without pain and I have the freedom to do the things I want to in life, said Getz. My daughter is moving overseas and I no longer worry about being in pain the whole fight.
Some patients do experience problems with spinal cord stimulation. Frequently reported problems following the implant surgery include infection, lead movement, pain at the implant site, loss of therapy effect, and therapy that did not meet the patient’s expectations. Neurostimulation is not for everyone, and a prescription is required.
Next on the agenda for Getz are additional projects around the house. I’m hoping these will be smooth sailing all around, Getz added.
This article written and provided by Medtronic October, 2016.
- Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomized controlled trial in patients with failed back surgery syndrome. Pain. 2007;132:179-188.
- IMV Benchmark Report 2012. IMV Medical Information Division. Des Plaines, Illinois. Page 1.
- Desai MJ, Hargens LM, Breitenfeldt MD, Doth AH, Ryan MP, Gunnarsson C, Safriel Y. The rate of magnetic resonance imaging in patients with spinal cord stimulation. Spine. 2015 May 1;40(9):E531-7.
NEUROSTIMULATION SYSTEMS FOR PAIN THERAPY
Brief Summary: Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure.
Indication for Use – Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks.
For full prescribing information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at medtronic.com.