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Abbott receives FDA approval for recharge-free neurostimulation system
Abbott announced it has received FDA approval for its recharge-free neurostimulation system, Proclaim XR, for patients with chronic pain.
According to a company press release, the Proclaim XR platform offers a low dose of Abbott’s BurstDR stimulation waveform, which extends the system’s battery life for up to 10 years. The release noted the Proclaim XR system was developed based on results from the BurstDR Microdosing Stimulation in De-Novo Patient study, which showed all of the 24 patients on a low-energy BurstDR-dosing program experienced pain relief with less than 6 hours of battery use per day. The results also showed 50% of the 24 patients achieved pain relief with the lowest effective dose and that, even when the highest settings were used, the systems were still in use 25% of the time.
Use of Apple mobile digital devices and Bluetooth wireless technology allows Proclaim XR to discreetly manage pain and fit seamlessly into a patient’s lifestyle, according to the release.
“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,” Keith Boettiger, vice president of Abbott’s neuromodulation business, said in the release. “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 is committed to developing life-changing solutions and putting the patient at the center of everything we do.”
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