Medtronic gets FDA approval to sell 'pain pacemaker'

Patients can be entrusted to take their own medication. So why not empower them to zap their spinal cords with small bursts of electricity if they're experiencing intense back or leg pain?

That's the idea behind a new "pain pacemaker" that Fridley-based Medtronic Inc. received regulatory approval to sell Wednesday. The device, about the size of an ultra-slim pocket watch, is implanted under the skin, usually in the abdomen, and connected to the spinal cord using insulated wires.

The neurostimulator sends small electrical pulses to a space near the spinal cord, preventing pain signals traveling through the nervous system from reaching the brain.

But patients suffering from back and leg pain find that the intensity and location of the pain can fluctuate, said Dr. Alon Y. Mogilner, chief of Functional and Restorative Neurosurgery at North Shore-LIJ Health System in Great Neck, NY. Many patients desire the ability to change the device's setting to treat changing patterns of pain.

Medtronic's RestoreULTRA device, which was approved by the Food and Drug Administration Wednesday, allows patients to tailor the electrical stimulation to the pain they're experiencing using an external remote control.

Previous-generation devices could be switched on and off, and the amount of electricity turned up or down. But the RestoreULTRA device's 16 electrodes allows the patient to target specific areas for stimulation.

Although Medtronic pioneered the neurostimulation medical device market, treating conditions such as chronic pain and Parkinson's disease, the company in recent years has been hit by beefed-up competition from Boston Scientific Corp. and St. Jude Medical Inc., and a lack of new, innovative products, said Stanford Group analyst Jan David Wald.

But the RestoreULTRA device "is a nice addition" to its neurostimulation device portfolio, he said.

The neurostimulation market is estimated to be more than $800 million worldwide, including companies as large as Medtronic and small start-ups that are testing devices to treat a range of maladies, from obesity to eye diseases. (Medtronic does not break out sales of individual devices.)

On Wednesday, shares of Medtronic closed at $46.92, up 9 cents.

Janet Moore • 612-673-7752