St Jude's five-column neurostimulation lead gains EU and Australian approval

10 Dec 2010

St Jude Medical, Inc. (NYSE:STJ) has received the European CE Mark and regulatory and reimbursement approval from the Australian Therapeutic Goods Administration (TGA) for its Penta surgical lead for neurostimulation therapy.

The company says that its five-column surgical lead is the first of its kind, featuring the smallest electrodes on the market. Although the Penta lead is only 10.9 mm wide, it offers the broadest lateral electrode span of any neurostimulation paddle lead.

St Jude 5-column neurostimulation leadThis feature is made possible by a proprietary micro-texturing process that enables greater amounts of current to be delivered via the small electrodes. The result is a lead that can more specifically focus current over a greater lateral area of the spinal cord, which may provide better coverage for managing chronic pain.

“Early adoption of the Penta lead in the US has been very promising, and we are encouraged by how well this paddle lead is aiding physicians in controlling low back pain,” said Chris Chavez, president of the St Jude Medical Neuromodulation Division. “We are excited to be able to make this first-of-its-kind product available to physicians in Europe and Australia.”

Spinal cord stimulation therapy, or neurostimulation therapy, is used for managing chronic pain of the trunk and limbs and pain from back surgeries that have failed. A lead is a small insulated wire with multiple electrodes 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.

“Neurostimulation therapy is often an appropriate choice for patients who have complex pain patterns,” said Dr. Ashwini Sharan, Associate Professor, Department of Neurosurgery and Department of Neurology at Jefferson Medical College and Thomas Jefferson University. “The five-column Penta lead provides the most comprehensive spinal cord coverage available, enabling us to specifically stimulate targeted areas in order to potentially better control the patient’s pain.”


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