St. Jude Medical Inc. (NYSE:STJ) won Japanese regulatory approval to market its Penta surgical lead for neurostimulation therapy to treat chronic pain.
The leads are used to provide electrical impulses near the spine to mask or interrupt pain signals. The lead is arranged in five columns to selectively stimulate certain nerves associated with the patient’s area of pain without affecting other nerves, according to a press release.
The Penta lead is already on the market in the U.S., Europe, Australia and Canada.
"Chronic pain is a largely under-treated and misunderstood condition that affects millions of patients worldwide," according to the release. "The World Health Organization, in conjunction with the International Association for the Study of Pain (IASP), reports that as many as one in five people suffers from moderate to severe chronic pain."
St. Jude has been active in the neuro-stim arena this year, including several U.S. regulatory wins.
St. Jude got the FDA green light in July for its Epiducer lead delivery system, a device that allows physicians to implant multiple neuro-stim leads through a single entry point. The clearance was the first of its kind in the U.S.
Last month it announced another med-tech first with a European CE Mark approval for its Genesis implanted neurostimulation device for patients with chronic migraines. Genesis was the first device of its kind to win regulatory approval in any market.
St. Jude is also experimenting with using deep-brain stimulation for the treatment of another kind of pain – depression.
The St. Paul, Minn.-based company’s systems compete against some of the biggest players in the med-tech arena: Medtronic Inc. (NYSE:MDT), who won CE Mark for a fully implantable peripheral nerve stimulation device in May 2011; and Boston Scientific Corp. (NYSE:BSX), which won FDA clearance for its lead system in August 2010.
Early last month, the St. Paul, Minn.-based medical giant found itself embroiled in a lawsuit brought by a patient who accused St. Jude of providing the Penta lead to two surgeons allegedly botched the implantation surgery.
Deirdre Murphy claimed St. Jude failed to do a proper background check on surgeons Douglas Slaughter and Charles Pace, neither of whom had performed a paddle lead procedure prior or received any training from the company, before selling them its Penta paddle lead.