FDA approves spinal cord stimulation system for broad treatment of chronic pain
Click Here to Manage Email Alerts
The FDA has granted premarket approval for Abbott’s Proclaim Plus spinal cord stimulation system, which can treat chronic pain across up to six areas of the body and is programmable to adjust to a person’s needs, the company announced in a release.
The Proclaim Plus system features FlexBurst360 therapy, the next generation of Abbott’s BurstDR stimulation technology, the release stated. The system is recharge-free with a battery that can last up to 10 years and can be used with Abbott’s NeuroSphere Virtual Clinic technology, which allows in-app video chatting capabilities with a physician, as well as remote stimulation settings, according to the release.
“Spinal cord stimulation has provided tremendous relief for patients suffering from chronic pain,” Steven Falowski, MD, of Argires Marotti Neurosurgical Associates of Lancaster, said in the release. “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.”
According to the release, the BurstDR platform delivers pulses of mild electrical energy to alter pain signals traveling from the spinal cord to the brain. Clinical studies have shown the technology delivers superior pain relief compared with tonic stimulation, with 87% of patients preferring the BurstDR technology.
The company also stated that with the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adjust for changing pain needs. Plus, the technology allows doctors to control multiple stimulation areas and provide expansive pain coverage without risking overstimulation.
“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,” Falowski said. “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.”