The Medtronic Inc. has won the CE Mark approval for a peripheral nerve stimulation device for treating chronic back pain. This medical device maker from Minneapolis, Minn. said the implantable device will fit into its neurostimulation business, which operates out of the company's restorative therapies division. That unit was responsible for about $5.42 billion in sales during the nine-month period ended Jan. 28.
The experts explained that peripheral nerve stimulation (PNS) using a fully implantable system is not available in the U.S. This new PNS device uses percutaneous or skin leads to send electrical pulses to the peripheral nerves within the subcutaneous tissue in the lower back area, using Medtronic’s existing implantable neurostimulation systems, the company said.
Medtronic has other neurostimulation devices in pain management including Restore line of neurostimulation devices, which compete with similar devices made by rival Boston Scientific Corp. Medtronic also offers a line of neuromodulation devices to treat bladder incontinence.
St. Jude Medical has also received Australian approval for its Epiducer lead delivery system for spinal cord stimulation therapy, the medical device company announced Monday.
This system is designed to reduce procedural complexity and improve efficiency in the placement of neurostimulation leads used in spinal cord stimulation therapy for the management of chronic pain. It allows physicians to place multiple neurostimulation leads through a single entry point. Before the Epiducer system, the placement of multiple neurostimulation leads required several small incisions. Little Canada-based St. Jude Medical Inc. recently showcased the system at the International Neuromodulation Society 10th World Congress in London.
Chris Chavez, president of the St. Jude Medical's Plano, Texas-based neuromodulation division said, “Providing physicians with clinically relevant new products like the Epiducer system enables them to have more control and less procedural risk when providing patients with this life-changing therapy.” More than 75,000 patients in 40 countries have been implanted with St. Jude Medical neurostimulation systems.