August 24, 2022 – Abbott announced that the FDA has approved its new Proclaim™ Plus spinal cord stimulation (SCS) system featuring FlexBurst360™ therapy. The next generation of Abbott’s proprietary BurstDR™ stimulation, FlexBurst360 therapy offers pain coverage across up to six areas of the trunk and/or limbs and enables programming that can be adjusted as a person’s therapeutic needs evolve.
Designed to fit within a person’s life, the Proclaim Plus SCS system is recharge-free with a battery that can last up to 10 years. It can be used with Abbott’s NeuroSphere™ Virtual Clinic connected care technology, which allows a person to both communicate with a physician through secure in-app video chat and remotely receive stimulation settings in real time regardless of location.
More than 50 million people in the U.S. suffer from chronic pain and 88% of those have pain in at least two or more different areas of their body. SCS therapy, also known as neurostimulation, is an implanted device that sends mild electrical pulses to the nerves along the spinal cord, changing the way the body perceives pain signals, which can relieve chronic pain and improve quality of life. According to the U.S. Pain Foundation, chronic pain is the leading cause of people going to the doctor and costs the nation approximately $635 billion each year in healthcare, disability and lost productivity costs.
BurstDR therapy is Abbott’s exclusive stimulation technology that delivers pulses – or bursts – of mild electrical energy to alter pain signals as they travel from the spinal cord to the brain. Clinical studies have shown that BurstDR technology delivers superior pain relief as compared to tonic stimulation, improves people’s day-to-day life, and reduces the emotional suffering associated with pain. When compared to standard tonic stimulation technology, which provides a constant tingling sensation felt by the patient, 87% of people preferred BurstDR technology, which provides pain relief in a sub-sensory range not felt by the patient.
Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs. The system allows doctors control over multiple independent BurstDR stimulation areas to provide broader pain coverage without overstimulation risk.
The Proclaim Plus system with FlexBurst360 therapy is designed to fit seamlessly within a person’s life and therapy settings can be accessed using either a personal mobile device or through an Abbott-provided mobile device. Patients can use the same device to access Abbott’s proprietary NeuroSphere Virtual Clinic, a first-of-its-kind neurostimulation technology9 in the U.S. that allows patients to communicate with physicians, ensure proper functionality of their device, and receive remote adjustments to their therapeutic settings as needed.