– The US Food and Drug Administration has approved an mHealth wearable designed to help reduce abdominal pain in teenagers living with irritable bowel syndrome (IBS).
The FDA’s green light of Innovative Health Solutions’ prescription-only IB-Stim device continues a string of developments in the digital therapeutic field for treatment of bowel-related issues. Last month, researchers at the University of Chicago released early results of a mobile health study that tracks the daily activities of people with inflammatory bowel disease.
The IB Slim fits around the patient’s ear and delivers low-frequency bursts of electricity designed to stimulate certain cranial nerves associated with functional abdominal pain. The device is designed to be used for five-day segments over three weeks and in conjunction with other IBS treatment.
“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, PhD, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “Today’s action reflects our ongoing commitment to advancing the development of pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs.”
FDA approval through the de novo premarket pathway follows a study of 50 patients aged 11-18 in which treatment with the connected care platform was compared to a placebo device. According to researchers, the device “resulted in at least a 30 percent decrease in usual pain at the end of three weeks in 52 percent of treated patients compared to 30 percent of patients who received the placebo, and at least a 30 percent decrease in worst pain in 59 percent of treated patients compared with 26 percent of patients who received the placebo.”
Last September, researchers at UPMC’s Center for High-Value Health Care announced the receipt of a five-year, $6.3 million grant from the Patient-Centered Outcomes Research Institute (PCORI) to study whether traditional clinic-based care or a telehealth program using RPM technology can best help patients living with IBD. Also participating in the project are the Mount Sinai Health System in New York and Brigham and Women’s Hospital in Boston.
Like the University of Chicago study, healthcare providers and researchers see telehealth and mHealth as a tool for improving care management outside the hospital or doctor’s office. These treatments hold the potential of not only improve a patient’s health and wellness at home, but reducing flare-ups and other health concerns that result in costly emergency care and reduced outcomes.
“The reality of a chronic disease like IBD is that it doesn’t just exist when you go to the doctor – it is something that both impacts and is affected by your everyday activities, and understanding that dynamic is the key to an improved system of care,” said David Rubin, MD, an IBS expert and Professor of Medicine at the University of Chicago. “At the end of the day, it’s about quality of life. It’s about managing the day-to-day of chronic disease so that there can be more prevention and prediction, as well as better care.”
In 2014, the FDA approved a similar device, called the Electro Auricular Device, for use in acupuncture. In 2017 the agency OK’d the NSS-2 Bridge – also developed by Innovative Health Solutions – for treatment of symptoms related to opioid withdrawal. Another device, the Drug Relief aural neurostimulator developed by DyAnsys, received similar approval in 2018.
Researchers at the University of Oklahoma, meanwhile, are testing a similar mHealth wearable for treatment of people diagnosed with atrial fibrillation.