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St. Jude's Pain Management System Gains U.S. Approval

The medical device manufacturer's Epiducer lead delivery system-a neurostimulation system-received FDA approval and is now available in limited quantities.

Little Canada-based St. Jude Medical, Inc., announced Tuesday that its Epiducer chronic pain management system has hit the market after receiving clearance from the U.S. Food and Drug Administration.

According to St. Jude, the neurostimulation system is the first of its kind and allows physicians to place multiple neurostimulation leads through a single entry point.

Neurostimulation, also called spinal cord stimulation, is used for managing chronic pain of the trunk and limbs and pain from back surgeries that have failed. Mild electrical pulses are carried from the neurostimulator to a lead or leads that are placed in the epidural space near the spine to interrupt or mask the transmission of pain signals to the brain.

The Epiducer system allows physicians to introduce paddle leads-which have electrodes to stimulate the spinal cord-through a percutaneous entry, a puncture or minor incision. Before the Epiducer system, the placement of paddle leads was only possible through a laminotomy, a more invasive surgical procedure that typically requires removal of part of the vertebral bone, St. Jude said in a statement.

The system received regulatory approval in Europe in May and is also available inAustralia and Canada. St. Jude said the company has received positive physician feedback in those markets.

Tom Hickman, vice president of marketing of St. Jude's chronic pain therapies division, told Twin Cities Business that the Epiducer lead delivery system is available in limited quantities now in the United States. He said that the company is ramping up manufacturing to increase availability and will have a broader release in the fourth quarter.

St. Jude is among Minnesota's 20-largest public companies based on its revenue, which totaled $5.17 billion in 2010.

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