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FDA Clears 'Recharge-Free' Neurostimulation Device for Chronic

Pain
Megan Brooks

September 27, 2019

The US Food and Drug Administration (FDA) has approved Abbott Laboratories' Proclaim XR neurostimulation system for
chronic pain patients. The device has a battery life of up to 10 years, the company announced.

The Proclaim XR platform uses the company's proprietary low energy BurstDR stimulation waveform coupled with a low
dosing protocol to provide effective pain relief with lower doses of stimulation, which significantly extends the system's
battery life.

"Abbott's low-dose and low-energy pain management technology is designed to provide pain relief and improve system
longevity, offering patients a life-altering option for pain relief without the hassles of recharging," the company said in a news
release.

Alternative neurostimulation systems may use higher frequencies or multiple waveforms that use more energy, requiring
them to be recharged daily. The Proclaim XR system allows physicians to identify the lowest effective dose of BurstDR
stimulation customized to each patient, optimizing the longevity of the system while maintaining effective pain relief, Abbott
said.

The Proclaim XR system was developed based on positive results from the BOLD study in which all 24 enrolled patients on
a low-energy BurstDR dosing program saw pain relief with < 6 hours of battery use per day. About half of those patients
achieved pain relief with the lowest effective dose (< 2 hours of daily battery use).

"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 CEO of The
Spine and Nerve Center of the Virginias in Charleston, West Virginia, said in the release.

"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," said Deer.

"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," Jacqueline Weisbein, DO, Napa Valley Orthopaedic Medical
Group in Napa, California, commented in the release.

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Cite this: Megan Brooks. FDA Clears 'Recharge-Free' Neurostimulation Device for Chronic Pain - Medscape - Sep 27, 2019.

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