FDA Approves Abbott’s Proclaim Plus Spinal Cord Stimulation System

The FDA has approved Abbott’s Proclaim Plus spinal cord stimulation (SCS) system, which features FlexBurst360 therapy and BurstDR stimulation.

FlexBurst360 offers therapy for pain coverage across up to 6 areas of the limbs and/or trunk, and it allows programming that can be adjusted to fit individuals’ needs.

The Proclaim Plus SCS system has a recharge-free battery lasts for up to 10 years. It can be used in conjunction with Abbott’s NeuroSphere Virtual Clinic, which connects patients and physicians to allow for secure in-application video chat and remote access to stimulation settings in real time, regardless of location.

“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,” Steven Falowski, MD, from the Argires Marotti Neurosurgical Associates of Lancaster, in Pennsylvania, said in a statement.

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, Falowski said.

BurstDR therapy is a 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, Abbott said in the statement.

Clinical study results have shown that this technology is effective at delivering pain relief compared with tonic stimulation, improving everyday life and reducing the emotional suffering associated with pain.

Investigators also reported that, when compared with standard tonic stimulation, which is a constant tingling sensation, approximately 87% of patients preferred BurstDR technology, which provides pain relief in a sub-sensory range that is not felt.

When using the FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each individual and adapt it based on pain needs. Physicians can control multiple BurstDR stimulation areas to provide pain coverage without the risk of overstimulation.

The Proclaim Plus system along with the FlexBurst360 therapy is designed to fit into an individual’s life and therapy settings either through their personal mobile devices or mobile devices provided by Abbott.

Patients can use the same device to access the NeuroSphere Virtual Clinic in the United States, which connects them with physicians, ensuring the functionality of their devices and providing remote therapeutic therapy adjustments as needed.

Reference

FDA approves Abbott’s new spinal cord stimulation device; provides tailored relief to multiple pain areas and adds more treatment options for evolving pain conditions. News release. Abbott. August 23, 2022. Accessed August 24, 2022. https://abbott.mediaroom.com/2022-08-23-FDA-Approves-Abbotts-New-Spinal-Cord-Stimulation-Device-Provides-Tailored-Relief-to-Multiple-Pain-Areas-and-Adds-More-Treatment-Options-for-Evolving-Pain-Conditions