MENLO PARK, Calif.--(BUSINESS WIRE)--Spinal Modulation, a privately held international medical device company, completed enrollment of the ACCURATE study, a randomized, controlled pivotal clinical trial designed to evaluate the safety and efficacy of the company’s Axium® Neurostimulator System.
The Axium System is a targeted form of spinal cord stimulation (SCS), which uses an implantable medical device to deliver mild electrical pulses that mask or interrupt pain signals as they travel from the periphery to the brain. Unlike traditional SCS devices, the Axium System uniquely targets the dorsal root ganglion (DRG), a neural structure within the spine that has been shown to play a critical role in the development and maintenance of chronic pain1.
The ACCURATE study enrolled 152 patients at 22 centers throughout the United States. This represents the largest neuromodulation study to be conducted in patients suffering from nerve injuries (peripheral causalgia) or complex regional pain syndrome (CRPS, also known as RSD) to date.
“Approximately 10-50% of patients who undergo common procedures like hernia repair, knee surgery, and other lower limb surgeries will suffer from chronic pain resulting from nerve injury2. These conditions have historically been difficult to treat with currently available technology,” said Dr. Timothy Deer, co-study lead and CEO and President of the Center for Pain Relief in Charleston, West Virginia. “The ACCURATE trial is a landmark study that could change the way we treat these chronic pain conditions. Results from prior European studies have been promising, and we are hopeful that the ACCURATE trial will continue to substantiate the effectiveness of this therapy for our patients.”
Investigators will present the ACCURATE trial design at the 18th Annual North American Neuromodulation Society (NANS) meeting in Las Vegas, Nevada, December 11 – 14, 2014. Clinical outcomes from Europe and Australia, where the Axium System is commercially available, will also be presented.
For a full list of Spinal Modulation research abstracts that will be presented at NANS 2014, go to www.spinalmodulation.com/nans2014. For more information about NANS 2014, including a full schedule of events, go to http://www.neuromodulation.org/Meetings/2014-Annual-Meeting/2014-annual-meeting.html
About Chronic Pain
Chronic neuropathic pain is a condition that affects millions of Americans annually, impacting their ability to lead productive working, social and family lives. Neuropathic pain is induced by an injury or disease of the nervous system. The most common location for neuropathic pain is the lower limbs3; including areas such as the legs, feet, and groin area. Patients suffer from a wide variety of pain sensations including stabbing, burning, pins and needles, and numbness.
About the Axium® Neurostimulator System
The Axium Neurostimulator System is a form of spinal cord stimulation (SCS) that targets a neural structure within the spine called the dorsal root ganglion (DRG). The DRG contains the primary sensory neurons that transmit pain signals from the peripheral nerves to the brain. The system uses an implantable medical device to deliver mild electrical pulses to the DRG. These pulses mask or interrupt pain signals as they travel to the brain. The Axium Neurostimulator System has CE Mark in the European Union and TGA approval in Australia for the management of chronic, intractable pain.
About the ACCURATE study
The ACCURATE study is a prospective, randomized, multi-center, controlled study to evaluate the safety and efficacy of Spinal Modulation’s Axium Neurostimulator System for the treatment of chronic pain affecting the lower limbs. It is the largest U.S. pivotal trial to evaluate spinal cord stimulation therapy in patients with lower limb pain due to nerve injuries (peripheral causalgia) or complex regional pain syndrome (CRPS).
About Spinal Modulation
Spinal Modulation is dedicated to improving the lives of patients with chronic pain by providing the next generation of neuromodulation systems through stimulation of the dorsal root ganglion. Spinal Modulation is a global medical device company based in Menlo Park, CA, Belgium, and Australia. The company is funded by St. Jude Medical, Johnson and Johnson Development Corporation, Medtronic, Kleiner Perkins Caufield and Byers, De Novo Ventures, MedVenture Associates, DFJ InCube Ventures, DFJ ePlanet Ventures, Raffles Venture Partners, The Angels Forum and The Halo Fund. In June 2014, St. Jude Medical signed an equity investment and option to purchase Spinal Modulation. The agreement provides St. Jude Medical immediate international distribution rights for the Axium Neurostimulator System and a longer term exclusive option to acquire the company following the achievement of certain milestones.
CAUTION: The Axium Neurostimulator System is an investigational device and is limited by United States law to investigational use.
SPINAL MODULATION, the circle symbol and Axium are registered and unregistered trademarks of Spinal Modulation, Inc. and its related companies.
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