Minneapolis-based ShiraTronics designed the neuromodulation system to address the debilitating symptoms of migraines. The company says it offers the first-ever fully implantable system for head location utilizing a minimally invasive approach.
The fully implantable, programmable device delivers electrical pulses tailored to disrupt migraine pain signals. ShiraTronics designed it to offer a new and potentially more effective treatment option. The device won FDA breakthrough device designation in 2021.
“It is gratifying and humbling to witness the evolution of this innovative approach to treating chronic migraine. Originating as a visionary concept by a creative group of physicians, it has now materialized into a tangible reality that has the potential to restore quality of life to many enduring this debilitating condition,” said Lynn Elliott, ShiraTronics’ co-founder.
The implants came as part of the RELIEV-CM study, conducted in partnership with leading Australian researchers. ShiraTronics expects it to establish a foundation for future clinical studies.
“The achievement of this crucial milestone has validated all aspects of our procedure, system, and therapy settings. Notably, it is encouraging that all six patients who completed the trial procedure opted for the permanent implantation of the ShiraTronics system,” CEO Rob Binney said. “We are thankful for the invaluable guidance and contributions by our investigators to date and look forward to additional patient implants currently scheduled in the new year.”
