FDA clears neurostimulation lead delivery system


The Food and Drug Administration (FDA) has cleared the Epiducer (St. Jude Medical), a lead delivery system for neurostimulation therapy. This first-of-its-kind system allows physicians to place multiple neurostimulation leads through a single entry point. 

The Epiducer lead delivery system reduces the need for multiple incisions typically required to place more than one neurostimulation lead utilised in spinal cord stimulation therapy for the management of chronic pain. The system also allows physicians to introduce St. Jude Medical S-Seriespaddle 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 optimise 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 utilising multiple lead arrays to treat complex multifocal pain, and we are excited to bring it to the US 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.”

According to a new report from the Institute of Medicine (IOM) of the National Academies, chronic pain affects an estimated 116 million American adults ─ more than the total affected by heart disease, cancer, and diabetes combined. Pain also costs the nation up to US$635 billion each year in medical treatment and lost productivity. The IOM report calls for coordinated national efforts of public and private organisations to create a cultural transformation in how the nation understands and approaches pain management and prevention. The study was mandated by Congress and sponsored by the National Institutes of Health.