FDA Approves Expanded MRI Labeling for Abbott's Eterna SCS System

Core Concepts

Abbott's Eterna SCS system receives FDA approval for expanded MRI labeling, enhancing patient care and access.

Abstract

The US FDA approved expanded MRI labeling for Abbott Laboratories' Eterna spinal cord stimulation (SCS) system, allowing higher-quality scan images for chronic pain patients. The Eterna system delivers low-intensity electrical impulses to disrupt pain and is the smallest implantable, rechargeable system for chronic pain treatment. The new labeling includes MR conditional leads, enabling safe MRI scans for chronic pain patients. The system offers faster scan times and higher-quality images, addressing barriers to efficient and effective scans for patients with implanted devices.

Stats

The Eterna SCS system delivers low-intensity electrical impulses to disrupt pain.
Eterna SCS is the smallest implantable, rechargeable system for chronic pain treatment.
The expanded labeling includes MR conditional leads for safe MRI scans.
The system offers faster scan times and higher-quality images.

Quotes

"Abbott's Eterna SCS system helps address these barriers and concerns with new [patients], as well as previously implanted patients, delivering improved patient care and access." - Steven Salkowski, MD
"With this label expansion, clinicians can now accelerate the steps required for imaging without compromising safety." - Pedro Malha, MBA

Key Insights Distilled From

FDA OKs Expanded MRI Labeling for Eterna SCS for Pain

by Kelli Whitlo... at www.medscape.com 05-15-2023

https://www.medscape.com/viewarticle/991960

Deeper Inquiries

How can the expanded MRI labeling for the Eterna SCS system impact the overall healthcare industry?

The expanded MRI labeling for the Eterna SCS system can have a significant impact on the overall healthcare industry by improving patient care and access for individuals with chronic pain. By allowing patients with SCS systems to safely undergo MRI scans, healthcare providers can more accurately assess the progression of illnesses such as cancer or multiple sclerosis in these patients. This expanded labeling can lead to better treatment decisions, earlier detection of complications, and overall improved outcomes for individuals with chronic pain. Additionally, the ability to obtain higher-quality scan images with faster scan times can enhance diagnostic accuracy and potentially reduce the need for additional testing or interventions, ultimately leading to more efficient and cost-effective healthcare delivery.

What potential drawbacks or limitations could arise from the increased use of MRI scans for chronic pain patients?

While the increased use of MRI scans for chronic pain patients can offer numerous benefits, there are also potential drawbacks and limitations to consider. One significant limitation is the possibility of increased healthcare costs associated with more frequent MRI scans. The use of MRI technology is expensive, and if chronic pain patients require more frequent scans due to their SCS systems, it could strain healthcare resources and lead to higher overall costs for both patients and healthcare systems. Additionally, there may be concerns about the potential risks of repeated exposure to MRI scans, such as the effects of magnetic fields on the body or the use of contrast agents in some imaging studies. Healthcare providers will need to carefully weigh the benefits of MRI scans against these potential risks and limitations to ensure the safety and well-being of chronic pain patients.

How might advancements in MRI technology influence the future development of spinal cord stimulation systems?

Advancements in MRI technology have the potential to significantly influence the future development of spinal cord stimulation systems by enabling more precise and personalized treatment options for individuals with chronic pain. With improved MRI capabilities, such as higher-quality images and faster scan times, healthcare providers can better assess the effectiveness of SCS systems and make more informed decisions about patient care. This enhanced imaging technology may also allow for the development of more advanced SCS systems that can be tailored to individual patient needs based on detailed MRI data. For example, MRI-guided placement of leads along the spine could optimize the delivery of electrical impulses and improve pain management outcomes. Overall, advancements in MRI technology are likely to drive innovation in the design and functionality of spinal cord stimulation systems, leading to more effective and personalized treatment options for individuals with chronic pain.