St. Jude Medical Announces FDA Clearance for Industry-First Neurostimulation Lead Delivery System for the Management of Chronic Pain

St. Jude Medical, Inc. STJ today announced the U.S. Food and Drug Administration (FDA) clearance and limited market release of the Epiducer™ lead delivery system for neurostimulation therapy. This first-of-its-kind system allows physicians to place multiple neurostimulation leads through a single entry point. Designed to reduce procedural complexities and enhance efficiency, the Epiducer lead delivery system reduces the need for multiple incisions typically required to place more than one neurostimulation lead utilized in spinal cord stimulation therapy for the management of chronic pain. The system also allows physicians to introduce St. Jude Medical S-Series™ paddle leads through a percutaneous entry. 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. In addition, this minimally invasive system enables physicians to deliver one, two or three different leads through a single entry point to configure and optimize the therapy for each patient. This allows for the management of complex and multifocal pain patterns such as low back pain combined with leg pain. “The Epiducer lead delivery system represents an important paradigm shift and step forward enabling physicians to configure patient-specific systems utilizing multiple lead arrays to treat complex multifocal pain, and we are excited to bring it to the U.S. market,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “This innovative system is already available in Europe, Australia and Canada, and physician feedback has been very positive regarding this new capability to deliver multiple lead configurations less invasively.”