By Eric Wicklund, mHealth Intelligence | September 30, 2019
The FDA has given the green light to an mHealth wearable developed by Abbott to help people dealing with chronic pain. It’s one of several devices that use targeted pulses of energy to help people manage pain.
The US Food and Drug Administration has approved an mHealth wearable that’s designed to relieve chronic pain for up to a decade without needing a recharge.
The FDA’s green light for Abbott’s Proclaim XR digital health platform follows the reported success of the company’s BOLD (BurstDR micrOdosing stimuLation in De-novo patients) study, in which 24 patients using the device reported pain relief within six hours, and half found relief within two hours.
The Proclaim XR wearable delivers low-dose electrical pulses to affect pain signals sent from the spinal cord to the brain. The device is one of several mHealth treatments that use targeted pulses of energy to reduce pain or cravings.
“For the 50 million people living with chronic pain in the United States this is a new and exciting treatment that is supported with evidence validated by the BOLD study, an established protocol for titrated intermittent dosing to give patients individualized pain relief while using therapy for 6 hours or less per day,” Timothy Deer, MD, president and chief executive officer of The Spine and Nerve Center of the Virginias in Charleston, WV, said in a press release issued by Abbott. “Proclaim XR is a major advancement in spinal cord stimulation, and is an evidence-based therapy that is mobile app-based and features upgradeable software. This means patients won’t need surgery to benefit from future advances in this technology.”
This past May, the FDA granted De Novo pre-market approval to Theranica Bio-Electronics’ Nerivio Midra digital therapeutic platform, which uses smartphone-controlled electronic pulses to the arm to relieve migraines through conditioned pain modulation. And in June, the agency OK’d Innovative Health Solutions’ prescription-only IB-Stim device, which fits around a patient’s ear and delivers low-frequency bursts of electricity designed to stimulate certain cranial nerves associated with functional abdominal pain experiences by those living with irritable bowel syndrome (IBS).
And last year, the UK’s National Health System launched a program to reimburse care providers who prescribe the ActiPatch mHealth wearable to help patients manage chronic pain.
In 2016, the Scripps Translational Science Institute in San Diego launched a project with Massachusetts-based NeuroMetrix to test the company’s Quell wearable and mHealth platform on patients with cancer.
“This primary end point was chosen to provide a novel way for patients with cancer to have optimal pain control while reducing their overall opioid use,” STSI officials said. “The study will also examine the potential benefits of Quell as a digital health intervention. The device integrates with a smartphone app that includes electronic pain tracking and provides objective feedback to the subject about their therapy utilization and sleep.”
Even the US Military is interested. In 2017, the Department of Defense announced an investment of some $6 million in a four-year project to develop mHealth tools for pain relief. Much of that investment is going into Cleveland-based SPR Therapeutics and its SPRINT Peripheral Nerve Stimulation (PNS) System, a wearable device designed to stimulate nerves around the affected part of the body to achieve pain relief.
“Many of our service members and veterans experience excruciating, debilitating post-amputation pain,” said Col (Ret.) Steven P. Cohen, MD, Director of Pain Research at Walter Reed National Military Medical Center, in a press release. “There is a clear military benefit to developing effective and innovative pain relief therapies and to providing treatment beyond conventional painkillers.”
Along with pain management, these connected health platforms are being designed to help people dealing with substance abuse issue control their cravings. They’re also being studied with an eye toward helping people with Parkinson’s and other neurological issues.
Abbott is touting its Proclaim XR platform as a means of personalizing pain treatment, in that doctors can adjust the settings on the device to deliver specific doses of energy. In some cases, that dose may be so low that the device doesn’t need to be recharged for 10 years.
“Proclaim XR is a new and differentiated advancement in how we approach chronic pain management, offering a safe and effective non-opioid technology for up to a decade of pain relief,” Jacqueline Weisbein, DO, of the Napa Valley Orthopaedic Medical Group in Napa, CA, said in the Abbott press release. “Having access to reliable pain relief – from a system that doesn’t have the hassle of needing to be recharged – is a game-changer in helping people live their best lives, free from pain.”