St. Jude Medical has announced FDA clearance of its Epiducer neurostimulation lead delivery system. The device allows surgeons to place a number of paddle leads, which are used in neurostimulation therapy to treat patients suffering from chronic pain, through a single, minimally invasive incision.
The device received European clearance about a year ago.
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 (SCS) therapy for the management of chronic pain. The system also allows physicians to introduce St. Jude Medical S-Series(TM) 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.