Tuesday, June 18, 2024

Chronic Pain Treatment: FDA Approves Abbott’s Spinal Cord Stimulation System

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Abbott’s Spinal Cord Stimulation (SCS) System has received the US Food and Drug Administration (FDA) approval to treat chronic pain in the torso, arms, and legs. This implantable device, known as a neurostimulator, is designed to offer significant relief to patients suffering from long-term pain conditions. The system includes several models: Prodigy, Proclaim Plus, Proclaim XR, and Eterna Systems. Each of these models is engineered to deliver tailored pain management solutions, addressing the unique needs of patients.

The Abbott SCS System operates by sending mild electrical pulses to the spinal cord, which helps to interrupt the pain signals before they reach the brain. This innovative technology aims to manage pain that is otherwise difficult to control through conventional treatments. By providing a consistent and effective method of pain relief, the system not only helps in reducing pain but also improves the overall quality of life for patients. These benefits are particularly valuable for individuals whose pain has been unresponsive to other therapies.

In addition to its primary function, the Abbott SCS System is equipped with advanced features that allow for personalized treatment plans. The device offers multiple types of stimulation, including “tonic” stimulation, which uses a steady stream of pulses, and “burst” stimulation, which uses groups of milder, faster pulses. This flexibility ensures that the treatment can be adjusted according to the specific pain management needs of each patient. Furthermore, the system is designed to be user-friendly, with both an external clinician programmer and a patient controller to facilitate easy operation and adjustments.

Abbott’s FDA-Approved SCS System: A Breakthrough in Chronic Pain Management

By obtaining FDA approval, Abbott has taken a significant step forward in the field of pain management. The SCS System’s ability to provide long-lasting pain relief can have profound effects on patients’ daily lives, enabling them to engage in activities that they might have otherwise found too painful. This approval is a testament to the efficacy and safety of the device, promising a new era of hope for those struggling with chronic pain conditions.

The Abbott SCS System consists of an implantable pulse generator (IPG) and lead wires, along with an external clinician programmer and patient controller. The system delivers mild electrical stimulation to the spinal cord to alleviate chronic pain. It offers two types of stimulation: “tonic,” which uses consistent strong pulses, and “burst,” which uses groups of milder and faster pulses. This flexibility allows for tailored pain management strategies for different conditions.

Approved on May 30, 2024, the Abbott SCS System is indicated for treating chronic pain in the torso, arms, and legs, including pain resulting from failed back surgery syndrome, non-surgical back pain, and diabetic peripheral neuropathy. However, diabetic peripheral neuropathy should only be treated with tonic stimulation.The spinal cord stimulator works by delivering electrical pulses to the spinal cord through electrodes in the lead wires, which are implanted near the spinal cord. The signal generator device, implanted near the hip, controls these pulses. This method can provide significant relief for patients suffering from chronic, intractable pain that has not responded to other treatments.

Chronic Pain

A New Hope for Patients with Untreatable Chronic Pain

Abbott’s SCS System can be particularly beneficial for managing pain that has not been successfully treated with surgery or for patients who are not candidates for surgery. By targeting the source of pain with electrical stimulation, the system can reduce the need for pain medications and improve overall patient outcomes. While the Abbott SCS System offers significant benefits, it is not suitable for all patients. Those who are unable to operate the system or who did not experience effective pain relief during trial stimulation should not use the device. It is crucial for healthcare providers to carefully evaluate each patient’s condition and suitability for the SCS System to ensure optimal results.

The approval of the Abbott SCS System underscores the ongoing advancements in medical devices designed to improve pain management and patient quality of life. As healthcare providers integrate this new system into their pain management protocols, it is expected to provide a valuable option for patients struggling with chronic pain.

The FDA’s approval of Abbott’s Spinal Cord Stimulation System marks a significant step forward in the treatment of chronic pain. This innovative device offers new hope for patients dealing with intractable pain in the torso, arms, and legs. As healthcare providers begin to adopt this system, it will be essential to monitor patient outcomes and gather data to further refine its use and effectiveness.

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Resource: Food and Drug Administration, May 30, 2024

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