Thursday, November 14, 2024

FDA Approves Abbott New Spinal Cord Stimulation Device

Abbott announced that the U.S. Food and Drug Administration (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.

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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 pain5 and 88% of those have pain in at least two or more different areas of their body.6 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.7

“Spinal cord stimulation has provided tremendous relief for patients suffering from chronic pain. With its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game-changer in this space, helping to not only improve a patient’s ability to perform everyday activities but also relieve the emotional suffering§ that pain can cause,” said Steven Falowski, M.D., Argires Marotti Neurosurgical Associates of Lancaster, Lancaster, Pa. “However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened by pain because of multiple painful areas and evolving pain over time. Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time.”

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 stimulation3, improves people’s day-to-day life, and reduces the emotional suffering§ associated with pain.4 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.

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