The US Food and Drug Administration (FDA) has approved the Proclaim XR recharge-free neurostimulation system for people living with chronic pain from Abbott, the company announces in a news release.
The Proclaim XR platform offers a low dose of Abbott’s BurstDR stimulation waveform, which is engineered to use low doses of mild electrical pulses to change pain signals as they travel from the spinal cord to the brain. The delivery of lower doses of spinal cord stimulation (SCS) helps extend the system’s battery life, allowing people to experience pain relief, without the hassle of recharging, for up to 10 years.
The platform is designed to deliver BurstDR stimulation intermittently, at low energy levels. It also uses Apple mobile digital devices and Bluetooth wireless technology to help users manage their pain.
The system was developed based on positive results from Abbott’s BurstDR micrOdosing stimuLation in De-novo patients (BOLD) study, which suggests that 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 approximately 50% of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use 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,” says Timothy Deer, MD, DABPM, president and chief executive officer of The Spine and Nerve Center of the Virginias in Charleston, WVa, in the release.
“Proclaim XR is a new and differentiated advancement in how we approach chronic pain management, offering a safe and effective non-opioid technology for up to a decade of pain relief,” adds Jacqueline Weisbein, DO, Napa Valley Orthopaedic Medical Group in Napa, Calif. “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.”
[Source(s): Abbott, PR Newswire]