A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported that the first patient in the PRISM (Precision Implantable Stimulator for Migraine) clinical trial was implanted.

This pivotal trial will assess the safety and efficacy of occipital nerve stimulation as a treatment for refractory migraine headache, and will use Boston Scientific's Precision neurostimulation system to treat migraine patients who do not respond to other available therapies, or who cannot tolerate the side effects of existing medications. The Precision implantable pulse generator will deliver electrical impulses to the occipital nerves located just under the skin at the back of the neck.

The first person to receive an implant in the trial was a 52-year-old woman who currently experiences more than 20 headache days per month, and has suffered from headaches for the last 32 years. The implant was performed by Benjamin Lampert, MD, director of the Center for Pain Management at St. John's Hospital (Springfield, Missouri).

“Occipital nerve stimulation may provide a valuable option for pain relief to headache sufferers who otherwise have no remedies available,“ Lampert said.

Medtronic said that the Precision neurostimulation system is the smallest rechargeable neurostimulator approved by the FDA for spinal cord stimulation to treat intractable chronic pain of the trunk and limbs. The use of the Precision neurostimulation system for treatment of refractory migraine headache is limited to investigational use only in the U.S.