Burst stimulation for Spinal Cord stimulation approved by FDA
The FDA has given the green light for physicians to utilize a new form of spinal cord stimulation. BurstDR uses ‘burst pulses’ of stimulation to the dorsal column to replicate the body’s own natural nerve impulse patterns. First developed in 2004 by Dirk De Ridder MD Ph.D. at University of Otago in Dunedin, New Zealand burst stimulation has been shown to be superior than traditional methods of ‘tonic’ therapy provided by current spinal cord stimulator devices. This follows close on the heels of the FDA approval for high-frequency spinal cord stimulation following the positive results of the SENZA randomized control trial.
The SUNBURST trial (Success Using Neuromodulation with Burst), an industry-sponsored, prospective, randomized, controlled, multi-centered trial) compared BurstDR device against tonic SCS therapy. 100 patients were randomized to either group. After 24 weeks, 85 patients showed statistically significant improvements in pain severity over traditional tonic SCS. The burst pulses provide paresthesia free usage of the device in the majority of patients.
For many patients, the paresthesias that accompany stimulation via the traditional tonic approach can be pleasant. The trial was also able to confirm the patient preference for the paresthesia free stimulation. The results of the trial were presented at the 19th annual meeting of the North American Neuromodulation Society (NANS) in Las Vegas, Nevada.
For patients who were previously implanted with St Jude SCS devices, many may be upgraded via a simple remote reprogramming of the device. For others who were implanted with earlier versions of the device, a battery change is required to implement the new BurstDR technology.
- St. Jude Medical Announces FDA Approval of BurstDR Stimulation, a New Superior Spinal Cord Stimulation Option for Patients Suffering from Chronic Pain. (2016, October 04). Retrieved October 05, 2016, from http://www.businesswire.com/news/home/20161004005719/en/St.-Jude-Medical-Announces-FDA-Approval-BurstDR.
- US National Institutes of Health. SUNBURST (Success Using Neuromodulation with BURST) Study (SUNBURST). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). NLM Identifier: NCT02011893.
- Thomas G. Ciccone Practical Pain Management Oct 2016
At North Shore Pain Management we provide advanced, evidence-based, multidisciplinary and cost-effective pain management. Our goal is to improve your ability to return to the activities you have been missing as well as provide a meaningful reduction in pain.