Stimwave announces first full body 3-Tesla MRI conditional neuromodulation medical implantable device

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The first US patients have been successfully implanted with Stimwave’s Wireless Pain Relief technology, the Freedom stimulator, for long-term treatment of chronic back and leg pain. The technology means that chronic pain patients are able to have 3-Tesla full body magnetic resonance imaging (MRI) examinations with the device.

The ability to have a full body, 3-Tesla MRI examination with this implant represents a significant advancement in the fields of diagnostic imaging and pain management, allowing for scans of the spine as well as functional MRI examinations. Other neuromodulation systems with MR-conditional labelling typically limit exams to just the head or limbs, or to older 1.5-Tesla MRIs. However, the majority of patients will be in need of an MRI procedure of the torso or spine regions during their lifetimes. The Stimwave MR labelling now 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 MRI evaluation was conducted by Frank G Shellock, a physiologist with over 30 years’ experience in the field. In a peer-reviewed paper published in Neuromodulation: Technology at the Neural Interface, Shellock concluded that, “in comparison with the current FDA approved MRI labelling 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 US patients implanted under the care of Sunil Panchal in January 2015 at the National Institute of Pain in Tampa, Florida.

“Having a fully MRI compatible system opens up neuromodulation as a therapy for patients that were not previously able to take advantage of such treatment because they need ongoing scans,” said Panchal. “Even if patients with chronic pain do not 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, 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, an orthopaedic 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.”

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