St. Paul, Minnesota —St. Jude Medical Inc. (NYSE:STJ) won 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 via leads placed inthe spinal canal to interrupt or mask the transmission of pain signals to the brain. The implantable device is intended for patients suffering from chronic pain in the back, arms and legs, including pain associated with failed back surgeries, according to a press release.
The approval and launch of the device is significant for 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, the company said. 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-overhaul efforts threaten its 2010 goal of 15 percent annual per-share earnings growth. The company said it still expects to log double-digit growth, however, in part by taking market share from competitors. Like presumably all U.S. medical device makers, St. Jude opposes a provision of the healthcare reform initiative that seeks to raise up to $4 billion a year through 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.