Pain management company SPR Therapeutics yesterday said it won FDA 510(k) clearance for its Sprint peripheral nerve stimulation system designed to provide chronic pain relief.
The Cleveland, Ohio-based company touted the Sprint system as the 1st reversible and minimally-invasive PNS to win FDA clearance for treating chronic and acute pain, including post-operative and post-traumatic pain.
“The FDA’s clearance comes at a critical time when physicians, patients and the U.S. healthcare system are seeking therapies to manage pain while reducing opioid use. SPR has developed a drug-free treatment for relieving chronic and acute pain. With more than 100 million Americans suffering from chronic pain, and more than two million people suffering severe acute and post-operative pain every year, we believe Sprint will be a game changer in the world of pain management. Patient access to this therapy has been made possible by support and research grants from the United States Department of Defense, the National Institutes of Health and the State of Ohio. We are grateful for the enduring dedication of our team of physician investigators, clinical professionals, engineers and business colleagues,” CEO Maria Bennett said in a press release.
The Sprint system design includes a coiled wire lead and small, wearable stimulator. The lead is placed percutaneously or through the skin to connect to the wearable stimulator which delivers electrical stimulation through the lead to provide pain relief.
“Sprint brings the benefits of PNS to physicians seeking safe and effective alternatives to opioids in the treatment of chronic and acute pain. Unlike all other PNS systems, Sprint does not require permanent implantation which should reduce invasiveness, risk and cost,” Dr. Peter Staats of the American Society of Interventional Pain Physicians said in prepared remarks.
SPR Therapeutics said data from a clinical study of the device, funded by the National Institutes of Health, revealed and associative 72% reduction in average pain with use of the device.
The company plans to release the device to select health care facilities in the U.S. shortly.