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FDA Approves Abbott's 'Low Dose' Neurostimulation Device for Chronic Pain

Abbott's Proclaim XR spinal cord stimulation system is recharge-free, uses a low energy therapy and low dosing protocol, and runs on a battery that lasts up to 10 years.

Chronic pain patients in the United States now have a new treatment option. FDA has approved Abbott’s Proclaim XR recharge-free neurostimulation system for people living with chronic pain.

The Proclaim XR platform offers a low dose of Abbott's BurstDR stimulation waveform, which was created based on scientific insights from doctors and research to mimic natural patterns found in the brain, the company said. It works by using low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain.

Abbott said the delivery of lower doses of spinal cord stimulation helps extend the system's battery life, allowing people to experience pain relief, without the hassle of recharging, for up to 10 years.

The company’s low-energy stimulation is based on finding the lowest effective dose as determined by the treating clinician for select patients. It delivers BurstDR stimulation intermittently, at low energy levels, while allowing people to experience the same level of pain relief. Proclaim XR also uses Apple mobile digital devices and Bluetooth wireless technology to help patients discreetly manage pain, Abbott noted.

The system was developed based on positive results from Abbott's BurstDR micrOdosing stimuLation in De-novo patients (BOLD) study, which showed 100% of 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of battery use per day, while about 50% of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use a day). Even at the highest settings, the systems were still in use only 25% of the time. Data from this trial was presented at multiple society meetings earlier this year, including the North American Neuromodulation Society (NANS) and the International Neuromodulation Society (INS).

“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 six hours or less per day," said Timothy Deer, MD, president and CEO of The Spine and Nerve Center of the Virginias in Charleston, W.Va. “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.”

Living With Chronic Pain On Her Terms

Sara Smith, 33, a trained medical technician and lover of the outdoors, was diagnosed with scoliosis as a child. In 2006, Smith had spinal fusion surgery, but maintained her active lifestyle until 2012 when she broke one of her spinal fusion bolts during a dirt biking accident. That accident marked the start of Smith’s debilitating chronic pain.

She tried physical therapy, injection therapy, and pain medications before being introduced to spinal cord stimulation therapy. Abbott said that in Smith’s clinical trial experience she reported a 75% reduction in pain and was one of the first patients to receive the Proclaim XR system.

“I didn't realize how much pain I was really in until the Proclaim XR system trial," Smith said. "I was able to reclaim my life and can be the involved mom and wife I was before my accident. My Proclaim XR device’s long battery life will allow me to be an active participant in my own life, without having to worry about finding someplace where I can charge my device.”

While Smith may never be completely pain-free, she said that her pain level is significantly reduced, allowing her to focus on the things that matter the most to her and her family.

“Proclaim XR is the latest advancement in patient-centric pain therapy – opening the doors for people who don't want to be burdened with the hassles of recharging. Recharge-free means patients can live their lives without the constant reminder of being in treatment,” said Keith Boettiger, vice president of Abbott's neuromodulation business. “This is a meaningful advancement for the millions of people who need new options when it comes to managing the effects of their chronic pain."

Abbott noted that the device is currently under review for a CE mark in Europe.

 

 

 

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