ShiraTronics initiates FDA IDE study for implantable neuromod

ShiraTronics announced that it initiated its FDA investigational device exemption (IDE) pivotal trial for its neuromodulation therapy.

The RELIEV-CM2 clinical study evaluates the company’s neuromodulation therapy for chronic migraine. Investigators completed the first implants in the U.S. and Australia, kicking off the evaluation of the system’s long-term safety and efficacy. In October, the company raised $66 million to support the launch of this trial.

Minneapolis-based ShiraTronics designed its minimally invasive implantable neuromodulation system to address the symptoms of migraines. The fully implantable, programmable device goes just beneath the skin in the head. It delivers precise electrical pulses tailored to disrupt migraine pain signals. ShiraTronics designed it to offer a new and potentially more effective treatment option.

Sign up for Blog Updates