FDA approves low-dose spinal cord stimulator for chronic pain

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proclaim abbottAbbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. The press release reports that the system works by using low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. It adds that the delivery of lower doses of spinal cord stimulation helps extend the system/s battery life.

Abbott’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 superior pain relief. Proclaim XR also uses familiar Apple mobile digital devices and Bluetooth wireless technology to help discreetly manage pain and fit seamlessly into a patient’s lifestyle.

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 programme experienced pain relief with less than six hours of battery use per day, while approximately 50% of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use per day).

Timothy Deer (The Spine and Nerve Center of the Virginias, Charleston, USA), says: “For the 50 million people living with chronic pain in the USA 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. 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.”

The Proclaim XR system allows, according to the press release, physicians to identify the lowest effective dose of BurstDR stimulation customised to each patient—optimising system longevity while maintaining effective pain relief, and eliminating the need for recharging (for up to 10 years at low-dose settings).  This patient-centric innovation is possible because of Abbott’s proprietary waveform and advanced battery technology that is integrated into Proclaim XR.


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