St. Jude Medical's neurostimulation device Genesis got approved for use in Japan, the St. Paul, Minn.-based medical device giant announced on Monday.

"The Japanese market is the second largest medical device market in the world," Tom Hickman, vice president of marketing of St. Jude's neuromodulation division, tells DOTmed News. "There are somewhere in the neighborhood of 3.5 million people with chronic pain in Japan...and we believe the introduction of the Genesis system and additional systems to follow in the Japanese market are going to help a lot of patients."

LONG ROAD TO JAPAN

Approved for sale in the U.S. by the FDA in 2001, the back pain-easing device took longer to reach Japan both because of the island nation's lengthy regulatory process and because the original makers of the device, Advanced Neuromodulation Systems, needed a way to distribute the product in Japan, Hickman says. They got the latter when they merged with St. Jude Medical, to become the company's neuromodulation division, a little over four years ago.

St. Jude, which has offices around the world, runs a 650-person outfit in Japan, says Hickman.

"With a strong footprint in Japan, it enables us to have seasoned, experienced representatives there to act as a launching pad for our success," he notes.

OTHER MARKETS

The Japanese Ministry of Health, Labor and Welfare's approval comes only months after Genesis gained a foothold in another major Asian market, with China's Food and Drug Administration giving the device the nod in November.

Genesis received a CE mark in 2000. In addition to most European Union countries, it is available for sale in Canada and Australia.

GATEWAY CONTROL

In all markets, the pacemaker-like neuromodulation device is approved for easing chronic pain of the trunk and the lower limbs.

Doctors don't know precisely why the device, which stimulates the spinal cord with mild electric jolts, helps relieve pain. The leading theory, known as the gate-control theory, is that the jolts produce a sort of sensory traffic jam that prevents pain detection mechanisms from working.

"It's not unlike when you hurt your arm and then your grandma told you to rub it," explains Hickman. "If you rub it effectively, as long as you did that, there is a signal overlay that causes you to not the feel the pain, and this works by a similar mechanism."

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