Looking to more effectively address the issue of lower back pain treatment without surgery, St. Jude Medical (St. Paul, Minnesota) reported the clearance of two spinal cord stimulation tripolar paddle leads for use with its Renew Neurostimulation System.
With three columns of electrodes, the company said these leads allow physicians more programming options to address complex pain patterns when using spinal cord stimulators. The leads were developed by the Advanced Neuromodulation Systems (ANS, Plano, Texas) business of St. Jude.
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.
St. Jude said that 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.
The Tripole 8C was originally not part of the "C" configuration but was added due to customer requests and provides 8 independently activated electrodes.
"The Tripole 16C was designed to optimize for low back stimulation," said Tom Hickman, VP of product management at ANS. "It's an addition to our armamentarium of having a very broad array of leads that are available for the physician to select," he told Medical Device Daily.
"Low back pain is one of the most difficult pain patterns to treat," said Gerald Hale, MD, of Tulsa Integrated Pain Services (Tulsa, Oklahoma). "The development of these new paddle leads improves our ability to treat this area through targeted, sustainable stimulation therapy." 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.
Spinal cord stimulators are implanted neurostimulation devices that are similar in function and appearance to cardiac pacemakers, except that electrical pulses are sent to the spinal cord instead of the heart. These "pain pacemakers" interrupt the pain signals' pathways to the brain by delivering low intensity electrical pulses to trigger selective nerve fibers along the spinal cord. Theses devices are currently approved by the FDA for the treatment of chronic pain of the arms, legs, and trunk, or pain resulting from failed back surgery
While Hickman acknowledged that other companies, such as Medtronic (Minneapolis) and Boston Scientific (Natick, Massachusetts), "have an indication" for the treatment of low back pain using their respective neurostimulation systems, "they don't have a lead for this. The Tripole 16C is the first lead that is a tripolar construct that is available on the market."
The significance of having a tripolar lead, Hickman said, is that the construction of the lead "provides flexibility and specificity to ensure that you can facilitate capture of low back pain."
He noted that the treatment of low back pain via spinal stimulation therapy has proven to be an elusive foe and that the introduction of this new lead could change how physicians are able to treat this condition.
Hickman said that one of the primary reasons why low back pain treatment is difficult is the variety of anatomical issues.
It relates to "where the nerves you want to stimulate are in relation to nerves that you don't want to stimulate and with regards to how deep that is within the spinal cord relative to the dorsal cerebral spinal fluid level."
Hickman characterized the patient population that could benefit from the stimulation therapy for the treatment of low back pain as "large" and "easily undertreated."
In the U.S. he said that only about 2% to 5% of the patient population that could benefit from this therapy is being treated by all of the above-mentioned U.S. competitors combined. Currently he said only about 20,000 to 25,000 implants are being done in the U.S. every year "relative to the hundreds of thousands of patients that have low back pain that could be treated for this."