St. Jude Medical, Inc. has announced U.S. Food and Drug Administration (FDA) clearance of two spinal cord stimulation tripolar paddle leads for use with the Renew Neurostimulation System.
With three columns of electrodes, these leads allow physicians more programming options to address complex pain patterns.
The leads were developed by St. Jude Medical’s neuromodulation division, Advanced Neuromodulation Systems (ANS).
The Lamitrode Tripole 16C and the Lamitrode Tripole 8C are designed to help patients suffering from one of the most common and difficult-to-treat patient indications, neuropathic low back pain. Often described as an intense burning or stabbing pain, neuropathic pain can be caused by an injury to nerves or by an underlying disease or dysfunction.
The Tripole 16C is the first three-column paddle lead with 16 independently activated electrodes, which can be programmed to send mild electrical pulses to low back nerve fibers while minimizing unwanted stimulation. These independent electrodes can also be programmed to provide stimulation to multiple areas for those patients who have pain in more than one area of the body.
“Low back pain is one of the most difficult pain patterns to treat,” said Gerald Hale, D.O., of Tulsa Integrated Pain Services in Tulsa, Okla. “The development of these new paddle leads improves our ability to treat this area through targeted, sustainable stimulation therapy.” Dr. Hale was one of the first to evaluate the design of these leads.
In 2004, ANS was the first to introduce a tripolar paddle lead. The Tripole 16C and Tripole 8C are the first tripolar leads with a curved surface to conform to the cylindrical shape of a patient’s spine, which is designed to make them more stable and less prone to migration.
“We are committed to developing new lead technology that provides physicians with the widest array of lead options, so they can choose the best lead to address each patient’s need,” said Chris Chavez, president of ANS.
Pain is a serious and costly public health issue, and it remains largely under-treated and misunderstood. According to the National Institutes of Health, 90 million people in the U.S. suffer from chronic pain. The American Pain Foundation estimates that chronic pain costs approximately $100 billion a year in lost work time and health care. More than 30,000 patients in 25 countries have been implanted with ANS spinal cord stimulation systems to treat chronic pain of the trunk and limbs.