Significant advancement for chronic pain treatment
On February 15, 2023, the U.S. Food and Drug Administration (FDA) announced the approval of the Prodigy Proclaim and Proclaim XR Spinal Cord Stimulation (SCS) systems. This approval marks a significant step forward in the treatment of intractable long-term chronic pain, particularly for patients who have not found relief with other therapies.
How they work
SCS is a type of neuromodulation therapy that uses an implanted device to deliver electrical impulses to the spinal cord, interrupting pain signals before they reach the brain. The Prodigy Proclaim and Proclaim XR systems use a new technology called BurstDR, which delivers bursts of high-frequency stimulation followed by periods of rest, mimicking the natural firing patterns of the spinal cord. This approach has been shown to provide greater pain relief than traditional SCS systems.
When are they used
The Prodigy Proclaim systems are used to help manage pain in the trunk and/or limbs. This includes pain on one or two sides that may result from a failed back surgery, intractable pain of the lower back and legs, and diabetic peripheral neuropathy that affects the extremities of the lower limbs.
Prodigy Proclaim system
The Prodigy Proclaim system is a rechargeable SCS device that can be programmed and controlled wirelessly using a handheld remote or a mobile app. It also features a proprietary algorithm that adjusts the stimulation automatically based on the patient’s activity level and pain patterns.
Prodigy Proclaim XR system
The Prodigy Proclaim XR system is a non-rechargeable device that can provide up to ten years of battery life. It also includes a new programming option called AutoAdapt, which automatically adjusts the stimulation based on the patient’s position and movement.
Clinical testing
Both systems have undergone rigorous clinical testing, including a randomized controlled trial that compared BurstDR to traditional SCS in patients with chronic back and leg pain. The trial showed that patients who received BurstDR experienced significantly greater pain relief and improvement in their quality of life.
Transformative innovation
In a statement, the FDA’s Center for Devices and Radiological Health Director Dr. Jeff Shuren praised the approval of the Prodigy Proclaim and Proclaim XR systems, saying that “innovations like BurstDR have the potential to transform the treatment of chronic pain and improve the lives of millions of Americans.”
The scope of chronic pain
Chronic pain affects an estimated 50 million Americans, and traditional treatments such as medication, physical therapy, and surgery are not always effective. SCS has emerged as a promising therapy for chronic pain, and the approval of the Prodigy Proclaim and Proclaim XR systems represents a significant advancement in this field.
Potential risks
It’s worth noting that like all medical devices, SCS systems are not without risks. Common side effects include pain at the implant site, infection, and device failure. Patients considering SCS should discuss the potential risks and benefits with their healthcare provider.
Conclusion
In conclusion, the FDA’s approval of the Prodigy Proclaim and Proclaim XR Spinal Cord Stimulation systems is a significant development in the treatment of chronic pain. With their advanced technology and proven effectiveness, these devices have the potential to improve the lives of millions of Americans who suffer from chronic pain.
Links
Read more about the approval of the Prodigy Proclaim systems here.
FDA Approval Order for the Prodigy Proclaim systems.
Summary of Safety and Effectiveness Data (SSED)