In an interview with PharmaShots, Dr. Allen Burton, Medical Director of Abbott’s Neuromodulation Business shared his views on the US FDA approval for expanded MRI compatibility of Its Proclaim XR SCS Device

Shots:

• The US FDA has approved new expanded MRI compatibility for its Proclaim XR Spinal Cord Stimulation (SCS) System with Octrode leads. The Proclaim XR SCS System is an implantable spinal cord stimulation device & is designed to allow patients to obtain relief from chronic pain in the trunk and limbs
• The new labeling lifts MRI restrictions for lead tip locations and radiofrequency power used as part of the standard operating mode of an MRI scan
• Under the expanded MRI labeling, Proclaim XR SCS device adds additional benefits to patients and healthcare providers, including higher quality imaging with faster MRI scan times & allows the patients to obtain necessary scans, and increases efficiencies for radiologists

Tuba: Discuss the key points of the FDA approval of new magnetic resonance imaging compatibility for Abbotts’ Proclaim system with Octrode leads

Allen Burton: In January 2022, Abbott announced the U.S. Food and Drug Administration’s (FDA) approval of new expanded magnetic resonance imaging (MRI) compatibility for its Proclaim XR Spinal Cord Stimulation (SCS) System with Octrode leads. With this MRI labeling expansion, people utilizing a Proclaim XR SCS device can benefit from higher quality images with reduced MRI scan times. The new labeling also lifts MRI restrictions for lead tip location and the amount of radiofrequency power that can be used as part of the normal operating mode of an MRI scan. This applies to new patients, and those already implanted with ProclaimXR SCS systems.

Tuba: What does this approval mean to patients, caregivers, and physicians?

Allen Burton: Abbott’s expanded MRI capabilities for its Proclaim XR system allows for patients to, for the first time, have full-body scans when the MRI is in normal operating mode. In addition, patients with a Proclaim XR SCS device only need to wait 30 minutes between scan cycles of 30 minutes, allowing them to safely receive an MRI scan in a fraction of the time. In general, the FDA requires radiologists to pause MRIs for anywhere from 30 to 60 minutes between scan cycles for patients with implants.

With these changes, the procedure is now simpler and more efficient, which allows radiologists to shorten scheduled scan times for patients with a Proclaim XR SCS.

Tuba: Can you put some light on how this new approval eliminates the restrictions for MRI lead tip location and the magnitude of radiofrequency power for the normal operating mode of an MRI scan?

Allen Burton: With the new labeling, Octrode lead tips can be placed anywhere they are needed along the spine (for example, in the cervical spine) and still be considered MR Conditional, which means a patient can undergo MRI scans within the approved outlined conditions. Radiofrequency energy no longer needs to be limited with Proclaim SCS and Octrode devices as long as the MRI is in the normal operating mode. 

MRI scanners use powerful magnets and radiofrequency energy to create detailed images of the inside of the body. Concern over how those magnets and radiofrequency energy could impact the placement of implantable devices led to conditions being placed on the use of MRIs when a patient had a particular device. Restricted MRI labeling adds a layer of complexity to both patients and radiologists, meaning they must find an imaging facility willing to modify their workflow and work within the MRI labeling limitations of the patient's implant which is exactly why our new labeling is so important in allowing patients this access.

Tuba: Discuss the key benefits of Proclaim XR spinal cord stimulation system for patients to attain relief from chronic intractable pain of the trunk and limbs.

Allen Burton: The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow people to obtain relief from chronic pain in the trunk and limbs. It works by using mild electrical pulses to change pain signals as they travel from the spinal cord to the brain.

Clinical studies have shown that the Proclaim XR SCS System provides consistent, repeatable, and superior* relief from pain, which can improve a person’s quality of life, their ability to work, spend time with their loved ones or be part of their communities. What’s more, the technology allows people to discreetly address their pain rather than having to carry multiple prescription medications with them wherever they go.

Superiority when compared to traditional tonic SCS.

Tuba: Can you please discuss additional benefits including high-quality images and faster scan times?

Allen Burton: Under the expanded labeling, patients with a Proclaim XR SCS device only need to wait 30 minutes between scan cycles of 30 minutes, allowing them to safely receive an MRI scan in a fraction of the time. If a scan exceeds a certain amount of time without a break, radiofrequency energy used during the scans has the potential to heat up the implanted device, which can damage the surrounding tissue. In general, the FDA requires radiologists to pause MRIs for anywhere from 30 to 60 minutes between scan cycles for patients with implants.

In addition, because MRIs can be used in normal operating modes with Proclaim XR SCS, the resulting image will be of higher quality than might otherwise be possible. This benefits overall outcomes for both patients and physicians involved.

Tuba: Following the US, in what other markets is Abbott exploring approvals of this device?

Allen Burton: Abbott’s Proclaim XR SCS System with MRI compatibility is approved for use in the United States by the U.S. Food and Drug Administration. We will continue to improve MRI capability in our neuromodulation platform around the world.

Tuba: How does Proclaim XR spinal cord stimulation system work?

Allen Burton: The Proclaim XR SCS system offers a low, intermittent dose of Abbott’s proprietary BurstDR stimulation waveform, which was created to mimic natural patterns found in the brain. Proclaim XR works by using BurstDR electrical pulses to change pain signals as they travel from the spinal cord to the brain. Pain can be discreetly managed by using familiar Apple mobile digital devices and Bluetooth® wireless technology with the Proclaim XR system, which allows it to fit seamlessly into a patient’s lifestyle. Proclaim XR offers upgradable software, allowing physicians to offer a patient-centric solution for pain relief.

Tuba: What studies or trials is this approval based on? Can you elaborate on the study design and results?

Allen Burton: MRI approval is based on engineering and safety testing which was rigorous and performed by Abbott’s world-class MRI R&D team. This team’s capabilities will be leveraged to continue to improve MRI labeling across our portfolio.

Tuba: What other devices are in the pipeline for pain relief?

Allen Burton: Chronic pain can negatively impact personal relationships, work productivity, and a person’s daily routine. Abbott is a global leader in the development of chronic pain therapy solutions, offering radiofrequency therapy and spinal cord stimulation therapy solutions, including BurstDR stimulation, and stimulation of the dorsal root ganglion in the portfolio of devices for the treatment of chronic pain. 

Abbott’s suite of neuromodulation technologies includes the Proclaim XR SCS System, Proclaim DRG Neurostimulation System (for people with chronic pain in the lower limbs caused by complex regional pain syndrome or causalgia), and NeuroSphere Virtual Clinic (a first-of-its-kind digital health platform technology that allows patients to communicate with physicians, ensure proper settings and functionality, and receive new treatment settings remotely as needed).

We will continue to innovate with ongoing research across all these areas.

Source: The Iowa Clinic

About Author:

Dr. Allen Burton, Medical Director of Abbott’s Neuromodulation Business. He is a board-certified anesthesiologist with an added certification in pain management and brings nearly 20 years of experience in patient care to Abbott, alongside a strong background in leading large-scale clinical research programs. Dr. Burton obtained his bachelor of science at the University of Notre Dame, medical doctorate at Baylor College of Medicine, and completed his residency at Brigham and Women’s Hospital, Harvard Medical School.

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