St. Jude gets Japanese approval for spinal cord stimulation system

St. Paul, Minnesota — Device maker St. Jude Medical Inc. has received Japanese regulatory approval to begin selling a spinal cord stimulation system for patients suffering from chronic pain.

The Genesis neurostimulator works by delivering mild electrical shocks to leads placed in a patient’s spinal canal to interrupt or mask the transmission of pain signals to the brain. The Genesis, a small device that’s implanted in patients, is intended for those suffering from chronic pain of the back, arms and legs, including pain associated with back surgeries that have failed, according to a statement from St. Jude.

The approval and launch of the device is significant to St. Jude because Japan is the second-largest medical-device market in the world, according to William Phillips, president of St. Jude Medical Japan.

The device comes with a programmer that allows patients to turn the system on and off and select from 24 different stimulation options, according to the statement.

More than 60,000 patients in 35 countries have been implanted with neurostimulation systems from St. Jude, according to the statement. It’s unclear how many of those were implanted with the Genesis system. A St. Jude spokeswoman didn’t immediately respond to an e-mail.

St. Jude said earlier this month that a weak global economy and health care overhaul efforts threaten its 2010 goal of 15 percent annual per-share earnings growth. The company said it expects double-digit growth, however, which it hopes to achieve in part by taking market share from competitors. Like presumably all U.S. medical device makers, St. Jude opposes a provision of the health care overhaul that seeks to raise up to $4 billion a year by a tax imposed on device firms.

In addition to products for chronic pain and neurological disorders, the 14,000-employee company sells devices for patients suffering from heart ailments.