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 FreedomTM 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).
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 inNeuromodulation: 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.”