FDA approves St. Jude Medical's Penta surgical lead for neurostimulation therapy

St. Jude Medical, Inc. (NYSE:STJ) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. market introduction of its new Penta™ surgical lead for neurostimulation therapy. Unveiled at the annual North American Neuromodulation Society meeting, the Penta lead is the first of its kind, featuring the smallest electrodes in the market arranged in five columns.

This innovative surgical lead provides the broadest lateral electrode span of any neurostimulation lead on the market – yet the paddle configuration is only 10.9 mm wide. The Penta lead’s unique design is made possible by a proprietary micro-texturing process which 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 hard to control chronic pain.

“The Penta lead provides surgeons with an innovative new approach to increasing targeted control in managing chronic pain through neurostimulation therapy,” said Chris Chavez, president of the St. Jude Medical Neuromodulation Division. “We are proud to unveil this next-generation surgical lead – yet another first-of-its-kind technological advancement from St. Jude Medical.”

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.

Chronic pain affects millions of patients worldwide. In the U.S., more than 76.5 million people are categorized as suffering from chronic pain by the American Pain Foundation. Estimates by the National Institutes of Health place the costs for lost work time and healthcare expenses at approximately $100 billion every year.

More than 60,000 patients in 35 countries have been implanted with St. Jude Medical neurostimulation systems. Patients can obtain more information about neurostimulation pain therapies at www.PowerOverYourPain.com.


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