FDA Approves Abbott’s Burst Stimulation Therapy For Chronic Pain

The US FDA has approved Abbott’s Proclaim Plus spinal cord stimulation (SCS) system featuring its pain management therapy, FlexBurst 360. Abbott’s device is designed to cover pain across up to six areas of the trunk or the limbs, and is outfitted with programming that can be adjusted to an individual’s needs. 

A Flexible Pain Management Device

More than 50 million people in the US suffer from chronic pain, with the majority having pain in at least two different areas of their body. Chronic pain is the most common reason for visiting the doctor, and it has been estimated to cost the country about $635 billion each year in healthcare, disability and lost productivity. 

Over-the-counter and prescription painkillers are commonly used to manage pain, while non-drug treatments include nerve blocks, physical therapy, acupuncture, and massages. 

Neurostimulation such as SCS is also an established way to manage pain. The process involves implanting a device that generates mild electrical pulses to the nerves along the spinal cord, which alters the body’s perception to pain. Traditional SCS utilizes tonic stimulation, which delivers pulses at a consistent frequency and amplitude. 

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The Benefits of Abbott’s Burst Stimulation Therapy

Abbott’s system uses burst stimulation, a novel form of SCS that produces pulses at a higher frequency and lower amplitude compared to tonic stimulation, and includes pulse-free intervals to allow for passive depolarization of the nerves. This better mimics naturally occurring nerve signals in the central nervous system. 

In clinical studies comparing Abbott’s burst stimulation technology and tonic stimulation, the former delivered superior pain relief and improved everyday life while reducing the emotional suffering associated with pain. An added benefit of burst stimulation is its ability to provide pain relief without paresthesia, which is an uncomfortable tingling sensation often felt under tonic stimulation.

Abbott’s system enables physicians to identify the lowest effective dose of stimulation for each patient and adapt it based on their changing needs, all while avoiding the risk of overstimulation. 

The system can also be connected to a mobile device to access Abbott’s virtual clinic, which allows patients to communicate with their physicians for online checkups and receive remote adjustments. 

Author

Joy Lin

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