Abbott has announced US Food and Drug Administration (FDA) approval of its Eterna spinal cord stimulation (SCS) system—which the company describes as the world’s smallest implantable, rechargeable spinal cord stimulator currently available on the market for the treatment of chronic pain.
Eterna SCS utilises Abbott’s proprietary low-dose BurstDR stimulation, the only SCS waveform technology with the highest level (1a) of clinical evidence, proven to reduce pain 23% more than traditional waveform technology approaches.5
The company states that it developed Eterna based on extensive studies with patients, physicians and caregivers to understand the unmet needs of people living with chronic pain and that these studies found that people wanted a smaller implant for comfort while reducing the need to charge the device daily or weekly. With patient needs front of mind, Abbott created Eterna to be recharged less than five times a year under normal use, making it the lowest recharge burden platform on the market.§1,2,3
Timothy Deer, president and chief executive officer of the Spine and Nerve Centers of the Virginias (Charleston, USA), said: “Abbott’s low-dose BurstDR stimulation is clinically proven to reduce pain, improve people’s ability to perform everyday activities, and reduce emotional suffering associated with pain.^6
“Until now, it wasn’t available on a rechargeable device that was this small, and that only needs to be charged a few times a year. This makes a big difference in comfort for many patients who now can have access to the best of both worlds—a small, best-in-class rechargeable device with superior stimulation therapy.”
Pedro Malha, Abbott’s vice president, neuromodulation, added: “At Abbott, we deliver products and solutions with the goal of simplifying healthcare, improving clinical outcomes and providing people suffering from chronic pain with the best experience possible. As we progress on this commitment, Eterna is the next major leap forward.
“Eterna is the smallest rechargeable spinal cord stimulator on the market, provides the longest therapy between charges and offers an optimised recharging experience—all key features when selecting the best overall system.”*§3,4
* Smallest size determined by volume in cubic centimetres.
^ Pain and suffering as measured by visual analogue scale.
§ Approximately one hour per month or three hours five times per year at standard (nominal) settings for BurstDR programmes: 30/90 dosing when programmed with amplitude of 0.6mA and all other BurstDR settings are left at default compared to recommended charging frequency and duration of competitors. Recommended recharge frequency and duration for competitor product described in their respective IFU.
1. Abbott. Eterna IPG Battery Recharge Characterization Report (90903492); 2022.
2. Abbott. Eterna IPG Elect Design Verification Report: Current Draw (90860050). 2022
3. Abbott. Eterna Lowest Recharge Burden Comparison Memo (MAT-2210739); 2022.
4. Abbott. Eterna SCS IPG Size Comparison Memo (MAT-2210151); 2022.
5. Karri J, Orhurhu V, Wahezi S, Tang T, Deer T, Abd-Elsayed A. Comparison of Spinal Cord Stimulation Waveforms for Treating Chronic Low Back Pain: Systematic Review and Meta-Analysis. Pain Physician. 2020 Sep;23(5):451-460. PMID: 32967388.
6. Deer T, Slavin KV, Amirdelfan K, et al. Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform. Neuromodulation. 2017;20(6):543-552.
