MENLO PARK, Calif. & NAPA, Calif.--(BUSINESS WIRE)--Spinal Modulation, Inc., a privately held global medical device company, today announced the first patient enrollment in its U.S. pivotal clinical trial. The ACCURATE Study is a prospective, randomized, multi-center, controlled trial that will evaluate the safety and efficacy of the Axium™ Neurostimulator System for the treatment of chronic lower limb pain. This announcement was made as industry leaders convened last week at the 20th annual Napa Pain Conference, where data were presented about European experience with the Axium System.
“This is a landmark study in the field of spinal cord stimulation”
“This is a landmark study in the field of spinal cord stimulation,” said Eric Grigsby, M.D., founder and medical director of the Napa Pain Institute and the center’s principal investigator. “The Axium System targets the dorsal root ganglion (DRG), a unique branch of the spinal cord that plays a critical role in the development and maintenance of chronic pain1. The recently published European data2 from a non-randomized study are promising – 78 percent of patients experienced pain relief in the lower limbs. I am excited to be the first in the country to participate in this important clinical trial.” The study is expected to enroll 152 patients in up to 25 medical centers in the U.S.
The ACCURATE Study will enroll patients with chronic lower limb pain caused by Complex Regional Pain Syndrome (CRPS) or nerve damage (peripheral causalgia). “Chronic post-surgical pain is a major unaddressed need. Up to 35 percent of patients who undergo hernia surgery and 50 to 85 percent of patients who undergo amputations suffer from chronic post-surgical pain3. The Axium Neurostimulator System can potentially expand treatment options for this large underserved patient group,” said Tim Deer, M.D., co-study lead and president-elect of the International Neuromodulation Society.
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 limbs4; 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 the only form of spinal cord stimulation (SCS) that targets a specific branch of the spinal cord 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. Key ACCURATE Study qualifications include the following: 1) age 22 to 75 years; 2) chronic pain affecting lower limbs for at least 6 months; 3) has not had lasting success with other treatments; and 4) has not previously used spinal cord stimulation for chronic pain. To learn more about the ACCURATE Study, visit www.ACCURATEstudy.com or call 1-888-978-8397.
About Spinal Modulation, Inc.
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, Calif., 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. St. Jude Medical has the exclusive option to acquire the company following the achievement of certain milestones and is the exclusive distributor of the Axium Neurostimulator System in international markets where it is approved for sale.
CAUTION: The Axium Neurostimulator System is an investigational device and is limited by United States law to investigational use.
Axium is a trademark of Spinal Modulation, Inc.
©2013 Spinal Modulation, Inc. All rights reserved.
1 Pope JE, Deer TR, Kramer J. A Systematic Review: Current
and Future Directions of Dorsal Root Ganglion Therapeutics to Treat
Chronic Pain. Pain Medicine. 2013.
2 Liem et al. A Multicenter, Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Dorsal Root Ganglion Neurostimulator System in the Treatment of Chronic Pain. Neuromodulation. 2013.
3 Macrae, W.A. Chronic post-surgical pain: 10 years on. British Journal of Anaesthesia. 2008.
4 Bouhassira et al. Prevalence of chronic pain with neuropathic characteristics in the general population. Pain. 2008.