CLEVELAND--(BUSINESS WIRE)--Neuros Medical, Inc., a medical device company, announced it has enrolled the first patients in its pivotal clinical trial to evaluate the Company’s patented Altius® System High Frequency Nerve Block technology for the management of intractable limb pain of amputees.
The prospective, randomized, controlled pivotal clinical trial will consist of up to 130 patients at 15 institutions to evaluate the safety and efficacy of Neuros Medical’s Altius System. When completed, the results will support a PreMarket Approval Application to FDA in order to market the device. The pivotal study builds off their long-term pilot study which reported significant pain reduction, up to 30 months. In addition, more than half of the responders discontinued their pain medication use during the study.
“The Neuros High Frequency Nerve Block has the opportunity to be a paradigm shift in treating chronic pain, especially post-amputation pain, due to its on-demand blocking effect, versus traditional stimulation,” said Dr. Leonardo Kapural, the study’s principal investigator, from the Carolinas Pain Institute in Winston-Salem, North Carolina.
Dr. Nagy Mekhail, Director of the Evidence Based Pain Medicine Research, Department of Pain Management at Cleveland Clinic added, “We are honored to be one of the initial implanting sites and part of this important study to investigate the Altius technology for patients with post-amputation pain.”
“We are excited to have our first implants underway as we execute our pivotal study, with our wave of sites commencing recruitment and enrollment,” stated Jon J. Snyder, President and CEO of Neuros Medical.
About Neuros Medical, Inc.
Neuros Medical, a Cleveland, Ohio based neuromodulation company, is focused on developing proprietary therapies for unmet needs to patients worldwide. The Company’s patented platform technology, Electrical Nerve Block, is focused on the elimination of chronic pain in a variety of conditions including amputation pain, post-surgical pain, migraine, and trigeminal neuralgia.
CAUTION -- Investigational device. Limited by Federal (or United States) law to investigational use.