Neurostimulation continues to be an area where large medical device companies are investing their considerable resources in the hopes of big returns.

Medtronic announced Thursday that the company has launched a clinical trial to evaluate the effectiveness of peripheral nerve stimulation to manage chronic back pain in people who had no relief even after surgery. The Minnesota device maker said that the first patients have been enrolled in the randomized, blinded, multicenter trial that intends to recruit up to 323 patients in 30 U.S. medical centers.

The data will support the premarket approval application to the FDA for a fully implantable peripheral nerve stimulation therapy for which Medtronic received European clearance in 2011. Through this therapy a patients are implanted with an electronic stimulator that delivers mild electric pulses through leads that are placed under the skin of the lower back. The zapping of the nerves in the lower back pain interrupts electrical signals traveling to the brain thereby potentially reducing the experience of pain.

“The SubQStim II pivotal study will provide new information about subcutaneous nerve stimulation as a potentially valuable treatment option for U.S. patients with chronic, intractable back pain who have found insufficient relief with other treatment options,” said Dr. George Mandybur, the study’s coordinating investigator, Associate Professor and Director Stereotactic and Functional Neurosurgery at the University of Cincinnati and a neurosurgeon with the Mayfield Clinic.

Aside from the PNS therapy for chronic back pain, Medtronic has a number of neurostimulation applications targeting incontinence, movement disorders and spasticity among other conditions.

An aging population is one of the factors driving the growth of the neurostimulation market, which is expected to be worth $6.8 billion globally in 2017. And Medtronic’s announcement comes a day after its in-state rival St. Jude Medical said that three deep brain stimulation devices – that also fall under the broad umbrella or neurostimulation – received CE Mark to treat primary and secondary dystonia.

By Arundhati Parmar, Senior Editor, MD+DI

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