FDA approves Burst DR spinal cord stimulation to treat chronic pain.- St Jude Medical

St. Jude Medical, Inc. has announced U.S. approval of BurstDR stimulation, a physician-designed form of spinal cord stimulation (SCS) clinically proven to provide superior outcomes for patients with chronic pain over traditional SCS therapy. With FDA approval of BurstDR stimulation, which is exclusive to St. Jude Medical, the company aims to help patients find relief from their pain and suffering while also providing patients a better experience with their chronic pain therapy. With FDA approval of BurstDR stimulation, patients receiving new implants of the St. Jude Medical Proclaim Elite and Prodigy MRI spinal cord stimulation systems will have immediate access to the new therapy. Combined, the Proclaim Elite SCS System and BurstDR stimulation offers patients the advantages of the St. Jude Medical Invisible Therapy portfolio and an entirely recharge free option, allowing patients to focus on their lives instead of their pain. In addition, patients previously implanted with upgradeable Prot�g� and Proclaim SCS systems will soon be able to upgrade their systems to deliver BurstDR stimulation without additional surgery.

Traditional SCS ( spinal cord stimulation) therapy is delivered via tonic stimulation, a mode of stimulation that refers to the frequency of the electrical energy that is delivered to interrupt the transmission of pain signals to the brain. Patients with a traditional SCS system feel the mild pulses of energy as a tingling sensation called paresthesia. Despite the fact that tonic stimulation is effective in up to 77 percent of patients, over time some pain practitioners have come to believe that effective coverage at the painful site or region may require the availability of alternate stimulation options or settings.Burst stimulation is a form of neurostimulation therapy that delivers closely-spaced pulses of electrical energy to a patient�s spinal cord to manage chronic pain. Burst stimulation may be a new option for patients whose pain is not adequately controlled, or for those who lose therapeutic benefit over time with tonic SCS alone. Early research indicates that burst stimulation may be able to deliver SCS therapy with little-to-no paresthesia and may be more effective than tonic stimulation, especially in managing complex back pain.