FDA Expands Clearance for OTC Pain Device

Deborah Brauser

February 04, 2020

The US Food and Drug Administration (FDA) has granted a new marketing clearance for the ActiPatch (BioElectronics Corp) — an over-the-counter electromagnetic neuromodulation device for treating pain, the manufacturer has announced.

The new 510(k) clearance is indicated for adjunctive treatment of any musculoskeletal pain. This joins previous FDA clearance granted for the noninvasive device in 2017 to treat knee osteoarthritis and plantar fasciitis.

"The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain in the back, knee, hips, wrists, elbow, ankle, etc," Keith Nalepka, vice president of sales and marketing at BioElectronics, said in a press release.

"The company intends to capitalize on this new clearance by offering additional products to retail channel partners," added Kelly Whelan, president of the manufacturer, in the same release.

BioElectronics noted that the ActiPatch "remains the only pulsed shortwave therapy device" with this type of over-the-counter clearance and indication.

Short-Term, Long-Term Benefits

On the company's website, the device is described as using rapidly pulsing electromagnetic waves "that are low enough so you cannot feel them but high enough to provide benefits." Patients are instructed to place the device's wire loop over an area of pan, attach it with the included tape, and then wear it up to 24 hours a day, as needed.

As reported by Medscape Medical News, results from a long-term prospective study of the ActiPatch were published in September in Pain Research and Management.

The study included 240 participants with chronic pain who had experienced pain relief from the device during an earlier, short-term study. Results from the long-term trial showed that 97% of the patients sustained a 60% reduction in pain at 6 months.

"The vast majority of people who get short-term relief from this medical device get that relief for at least 6 months, their quality of life improves, and it's a 'whole different ballgame' in terms of chronic pain," lead investigator Richard Staelin, PhD, Duke University, Durham, North Carolina, told Medscape Medical News at the time.

Asked to comment at the time, Imanuel Lerman, MD, a pain management specialist at the VA San Diego Healthcare System, California, noted that although there appeared to possibly be some clinically significant effects, more research should be conducted.

"I believe randomized, sham-controlled studies are needed to confirm any findings," Lerman told Medscape Medical News.

Staelin is an investor in and consultant for BioElectronics Corporation. Lerman has been a paid consultant for Boston Scientific and has received grants from Boston Scientific and Nevro Corporation.

Follow Deborah Brauser on Twitter: @MedscapeDeb.

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