The ability to have a full body, 3-Tesla MRI examination with this implant allows for scans of the spine as well as functional MRI examinations. Other neuromodulation systems with MR conditional labeling typically limit exams to just the head or limbs, or to older 1.5T MRIs. However, the majority of patients, more than 30 million in the United States, will need an MRI procedure of the torso or spine regions during their lifetimes, according to figures cited by Stimware. The Stimwave MR labeling allows patients with pain derived from cancer or cancer treatment, or severe spinal structural compromise, to benefit from neuromodulation without decreasing the long-term ability to diagnose and treat anatomical and structural issues.
The Stimwave MRI evaluation was conducted by Frank G. Shellock, Ph.D., a physiologist with more than 30 years’ experience in the field and considered one of the world’s foremost authorities on MRI issues for implants and devices. In a peer-reviewed paper published in Neuromodulation: Technology at the Neural Interface, Shellock concluded that, “in comparison with the current [U.S. Food and Drug Administration-] approved MRI labeling for other neurostimulation systems used for [spinal cord stimulation] that may have extensive restrictions, the MR conditions allowing patients to undergo MRI are substantially less limited [for the Stimwave device] and essentially allow MRI examinations to be performed on all body parts of the patient.”
The “full-body” 3-Tesla MR conditional rating for Stimwave’s Freedom Stimulator was instrumental for the first U.S. patients implanted under the care of Sunil Panchal, M.D., in January this year at the National Institute of Pain in Tampa, Florida.
“Having a fully MRI compatible system opens up neuromodulation as a therapy for patients that weren’t previously able to take advantage of such treatment because they need ongoing scans,” said Panchal. “Even if patients with chronic pain don’t require ongoing MRI scans now, choosing Stimwave’s Wireless Pain Relief technology keeps the door open for any MRI testing that patients may need in the future. Further, the option to consider neuromodulation systems rather than opioids to manage chronic pain is particularly important for human health as we learn more about the negative impact of continued drug use, which has been proven to increase and accelerate osteoporosis, elevate the risk of bone fractures, and contribute to cancer spreading faster.”
“As the population ages, the need for serial sophisticated diagnostic imaging, such as 1.5 and 3-Tesla imaging, becomes a necessary diagnostic tool to follow the evolution of our interventional therapies to determine treatment efficacy,” said Ralph Rashbaum, M.D., an orthopedic surgeon at Texas Back Institute. “Such is the case in patients being treated for severe intractable pain who have been responsive to spinal cord stimulators only to be later diagnosed with cancer. With the availability of Stimwave’s MR-conditional neuromodulation devices, such disorders as chronic pain in this patient population can treat their cancer while monitored by MRI.”
In addition, ligaments, cartilage and irregularities not visible with other diagnostic studies are visible using MRI, allowing physicians to diagnose or monitor treatments for a variety of medical conditions such as brain and spinal cord abnormalities, joint injuries, tumors, cysts, heart problems, and more. The health of patients implanted with other pain management systems that are not compatible with 3-Tesla MRI may be at higher risk due to undiagnosed medical conditions that go untreated without the detailed information that can be obtained via MRIs.