St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced European CE Mark approval of its new Epiducer™ lead delivery system for neurostimulation therapy. Unveiled at the Neurosurgery 2010 Congress in Lyon, France, the Epiducer lead delivery system is the first of its kind, allowing introduction of S-Series perc-paddle leads as well as multiple lead arrays through a single percutaneous entry point.
“One of this system's advantages is that it enables a physician to introduce a perc-paddle lead into the epidural space with a simpler, less invasive procedure”
This innovative lead delivery system is designed to reduce procedural complexities. The Epiducer system allows physicians to efficiently place neurostimulation S-Series perc-paddle leads and/or multiple lead arrays utilized in spinal cord stimulation (SCS) therapy for the management of chronic pain. Before the Epiducer system, the placement of paddle leads was only possible through a laminotomy, a more invasive surgical procedure, which typically requires removal of part of the vertebral bone.
"One of this system's advantages is that it enables a physician to introduce a perc-paddle lead into the epidural space with a simpler, less invasive procedure," said Dr. Olivier De Coster, an anesthesiologist who is head of the Pain Clinic at the Stedelijk Ziekenhuis Hospital in Roeselare, Belgium. "Paddle leads provide numerous therapy benefits including greater stability for reduced risk of migration and more efficient unidirectional stimulation."
Neurostimulation therapy is used for managing chronic pain of the trunk and limbs and pain from back surgeries that have failed. A paddle lead is a small insulated wire with multiple electrodes on a flat paddle-shaped surface that is placed in the epidural space near the spine. Mild electrical pulses are carried from the neurostimulator to the lead's electrodes to interrupt or mask the transmission of pain signals to the brain. Electrodes on the lead can be programmed to meet each individual patient's needs.
"We are pleased to provide physicians with this next-generation lead delivery system," said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. "The Epiducer system is redefining percutaneous procedures, presenting physicians with a unique, new option to place leads and reduce procedural complexities."
Three decades of leading edge neurostimulation technology
For more than 30 years, the St. Jude Medical Neuromodulation Division has developed new technologies to treat chronic pain and other neurological disorders. In the last year alone, the company has introduced 11 new neuromodulation products to aid physicians in the treatment of these conditions. Today more than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems.
Some of the innovative products that St. Jude Medical was first to bring to market include:
- World's smallest neurostimulator for chronic pain - the Eon Mini™ spinal cord stimulator
- Next-generation programming platform used to optimize neurostimulation therapy -- MultiSteering™ technology software for Rapid Programmer™
- First spinal cord stimulator with constant current circuitry - the Genesis™ neurostimulator
- World's smallest, longest-lasting rechargeable deep brain stimulation (DBS) device for treating the symptoms of Parkinson's disease -- the Brio™ neurostimulator (CE Mark approval)
Focused on research, St. Jude Medical is developing new technologies to address a growing list of neurological disorders. Clinical studies are currently underway for Parkinson's disease, essential tremor, migraine headaches, major depressive disorder, and others.
Chronic pain affects millions of patients worldwide. In the U.S., more than 76.5 million people are categorized as suffering from chronic pain by the American Pain Foundation. Estimates by the National Institutes of Health place the costs for lost work time and healthcare expenses at approximately $100 billion every year.