First Full Body 3-Tesla MRI Conditional Neuromodulation Medical Implantable Device

First Full Body 3-Tesla MRI Conditional Neuromodulation Medical Implantable Device

Stimwave Announces First Full Body 3-Tesla MRI Conditional Neuromodulation Medical Implantable Device (AIMD) Without Any Limitations for Body Part Imaging

MIAMI–(BUSINESS WIRE)–Stimwave Technologies Incorporated, a privately-held, commercial stage medical device company, today announced that the first U.S. patients have been successfully implanted with its Wireless Pain Relief™ technology, the Freedom™ Stimulator, for long-term treatment of chronic back and leg pain. For the first time, chronic pain patients are able to have 3-Tesla full body magnetic resonance imaging (MRI) examinations with this revolutionary active implantable medical device (AIMD).

“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”

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The ability to have a full body, 3-Tesla MRI examination with this implant represents a groundbreaking advancement in the fields of diagnostic imaging and pain management, allowing for scans of the spine as well as functional MRI (fMRI) 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, over 30 million alone in the U.S., will be in need of an MRI procedure of the torso or spine regions during their lifetimes. The Stimwave unique MR labeling 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 Stimwave MRI evaluation was conducted by Frank G. Shellock, Ph.D., a physiologist with over 30 years’ experience in the field and considered one of the world’s foremost authorities on MRI issues for implants and devices, with his work product highlighted on www.mrisafety.com. In a peer-reviewed paper published in Neuromodulation: Technology at the Neural Interface, Dr. Shellock concluded that, “in comparison with the current FDA approved MRI labeling for other neurostimulation systems used for SCS that may have extensive restrictions, the MR conditions allowing patients to undergo MRI are substantially less limited [for 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 FreedomTM Stimulator was instrumental for the first U.S. patients implanted under the care of Dr. 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 weren’t previously able to take advantage of such treatment because they need ongoing scans,” said Dr. 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 Dr. Ralph Rashbaum, 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 possible to see 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.

Please visit www.stimwave.com for more information on the availability of the Stimwave Wireless Pain Relief™ technology in the U.S.

 

Contacts

Glodow Nead Communications
Evan Nicholson, 415-394-6500
Sonia Meyer, 415-394-6500
stimwavepr@glodownead.com