DISCOVER
For your patients suffering from chronic foot pain
THE RIGHT FIT
UNDERSTANDING
YOUR PATIENTS’ PAIN
Due to its complexity, neuropathic foot pain is difficult to treat and often does not respond well to standard pain medication.
Approximately one in five patients living with diabetes will develop DPN, a long-term complication that can cause numbness, tingling, burning or stabbing sensations in the feet.
HEALTH CONDITIONS
THAT CAN RESULT
CRPS is described as intense, prolonged pain and inflammation that usually affects peripheral
limbs and begins with a traumatic injury, surgery, stroke or unknown cause.
RELY
ON ESTABLISHED TECHNOLOGY
Neurostimulation is an option for chronic pain that has been used for more than 50 years.
Before considering an implant, patients can trial the neurostimulation system first by using an external battery to see if it provides meaningful pain relief.
TEST-DRIVE BEFORE IMPLANT
THE THERAPY CONSISTS OF THREE COMPONENTS :
Thin wires that deliver electrical pulses
from the battery to nerves along the
spine or to the DRG.
LEADS
A small device that is connected to the
leads to supply power.
BATTERY
An iOS software-compatible app* that
enables patients to adjust the therapy
within prescribed settings.
PATIENT CONTROLLER
SCS THERAPY FOR BROAD PAIN
The Eterna™ SCS System is the smallest rechargeable implantable spinal cord stimulator on the market.
ETERNA™ SCS SYSTEM
With the Proclaim™ XR SCS System, patients can have hassle-free pain relief without ever needing to charge
their system.
PROCLAIM™ SCS SYSTEMS
DRG THERAPY FOR FOCAL PAIN
Clinical studies have demonstrated favorable outcomes in foot pain using DRG therapy.
PROCLAIM™ DRG SYSTEM
DRG pooled analysis showed a responder rate of 80% for patients with foot pain as the primary affected pain region.
DRG POOLED ANALYSIS
The average percentage of pain reduction was 81.4% from baseline at 12 months for the full lower-extremity cohort.
ACCURATE STUDY
1
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6-8
11, 12
6
13, 14
14
13§
CONNECT
WITH A LOCAL REPRESENTATIVE
Get in touch with a representative for more information about neurostimulation therapy and referral programs for your patients with chronic foot pain.
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third-party trademark, which is property of its respective owner.
*Available on eligible Apple mobile digital devices. For a list of personal Apple mobile digital devices compatible with Abbott’s Patient Controller app, visit http://www.NMmobiledevicesync.com/dbs or http://www.NMmobiledevicesync.com/cp.
**SCS systems from Abbott now offer DPN patients relief from chronic pain by delivering traditional tonic stimulation.
***The BurstDR™ stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population.
†Combined data from comparative studies in the Abbott Clinical Summaries IFU. Analysis of all randomized subjects in an intent-to-treat approach.
††Smallest size determined by volume in cubic centimeters. Based off comparison to volumetric measurement of the following IPGs: Boston Scientific WaveWriter Alpha 16, 20.1 cc; Medtronic Intellis , 13.9 cc; Nevro Omnia , 26 cc; Saluda Evoke , 33 cc.
†††Hassle-free means recharge-free.
§The responder rate was defined as ≥ 50% reduction in pain score.
1. Cohen SP, Mao J. Neuropathic pain: mechanisms and their clinical implications [published correction appears in BMJ.
2014;348:g2323]. BMJ. 2014;348:f7656. doi:10.1136/bmj.f7656
2. Martin CL, Albers JW, Pop-Busui R; DCCT/EDIC Research Group. Neuropathy and related findings in the diabetes
controland complications trial/epidemiology of diabetes interventions and complications study. Diabetes Care. 2014;37(1):31-
38. doi:10.2337/dc13-2114
3. Staudt MD, Prabhala T, Sheldon BL, et al. Current strategies for the management of painful diabetic neuropathy. J Diabetes
Sci Technol. 2022;16(2):341-352. doi:10.1177/1932296820951829
4. Wallace MS, North J, Grigsby EJ, et al. An integrated quantitative index for measuring chronic multisite pain: the Multiple
Areas of Pain (MAP) study. Pain Med. 2018;19(7):1425-1435. doi:10.1093/pm/pnx325
5. International Neuromodulation Society‡. Spinal cord stimulation’s role in managing chronic disease symptoms. Updated
August 3, 2022. Accessed June 13, 2023. https://www.neuromodulation.com/spinal-cord-stimulation
6. Abbott. Proclaim™ SCS Implantable Pulse Generator Clinician’s Manual. 2023.
7. Abbott. Eterna™ SCS Implantable Pulse Generator Clinician’s Manual. 2023.
8. Abbott. Proclaim™ DRG Implantable Pulse Generator Clinician’s Manual. 2018.
9. Abbott. Data on File. DPN Pain Relief Comparison Memo (MAT-2308037). 2023.
10. Abbott. Eterna™ SCS IPG Size Comparison Memo (MAT-2210151). 2023.
11. 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. 2018;21(1):56-66.
doi:10.1111/ner.12698
12. Abbott. Clinical Summaries for Spinal Cord Stimulation Systems Clinician’s Manual. 2023.
13. Huygen FJPM, Kallewaard JW, Nijhuis H, et al. Effectiveness and safety of dorsal root ganglion stimulation for the treatment
of chronic pain: a pooled analysis. Neuromodulation. 2020;23(2):213-221. doi:10.1111/ner.13074
14. Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex
regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial. Pain. 2017;158(4):669-681.
doi:10.1097/j.pain.0000000000000814
Abbott
8701 Bee Caves Rd., Bldg. 2, Austin, TX 78746 USA, Tel: 1 972 526 8286
Neuromodulation.Abbott
One in three American adults suffer from chronic pain.
IN CHRONIC FOOT PAIN INCLUDE:
BROAD NEUROPATHIC PAIN CONDITIONS
FOCAL NEUROPATHIC PAIN CONDITIONS
• Diabetic peripheral neuropathy (DPN)
Nerve damage can not only affect the injured site but also multiple areas surrounding it, and may have different causes such as nerve pain from an injury or inflammation. As pain evolves over time, 88% of chronic pain patients often have two or more distinct painful areas.
• Broad pain
Causalgia is defined as a painful condition arising from damage to a nerve. Nerve damage may
result from traumatic or surgical
nerve injury.
• Complex regional pain syndrome (CRPS)
• Traumatic foot or ankle injury (causalgia)
Spinal cord stimulation (SCS) systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with DPN** of the lower extremities.
5
The only FDA-approved DRG technology for the treatment of CRPS I and causalgia (CRPS II) of the lower extremities.
8
18X
PATIENTS WITH DPN ARE 18 TIMES MORE LIKELY TO EXPERIENCE SIGNIFICANT PAIN RELIEF
IF TREATED WITH SCS THERAPY
COMPARED TO CONVENTIONAL MEDICAL MANAGEMENT. ***
© 2023 Abbott. All Rights Reserved. 23-79114 MAT-2307380 v1.0 | Item approved for U.S. use only.
Important Safety Information
5
Neurostimulation therapy works by stimulating nerves along the spine or the dorsal root ganglion (DRG) using controlled electrical pulses to interfere with pain signals and alleviate pain.
Innovative features and clinically proven therapy make the Eterna™ SCS System the patient friendly choice
The Proclaim™ Plus SCS System with FlexBurst360™ therapy is designed to give relief to people who feel pain in more than one area.
Innovative features and clinically proven therapy make the Eterna™ SCS System the patient friendly choice.
The Eterna™ SCS System is the smallest rechargeable implantable spinal cord stimulator on the market.
‡
10
†††
9
1. Cohen SP, Mao J. Neuropathic pain: mechanisms and their clinical implications [published correction appears in BMJ. 2014;348:g2323]. BMJ. 2014;348:f7656. doi:10.1136/bmj.f7656
2. Martin CL, Albers JW, Pop-Busui R; DCCT/EDIC Research Group. Neuropathy and related findings in the diabetes control and complications trial/epidemiology of diabetes interventions and complications study. Diabetes Care.
2014;37(1):31-38. doi:10.2337/dc13-2114
3. Staudt MD, Prabhala T, Sheldon BL, et al. Current strategies for the management of painful diabetic neuropathy. J Diabetes Sci Technol. 2022;16(2):341-352. doi:10.1177/1932296820951829
4. Wallace MS, North J, Grigsby EJ, et al. An integrated quantitative index for measuring chronic multisite pain: the Multiple Areas of Pain (MAP) study. Pain Med. 2018;19(7):1425-1435. doi:10.1093/pm/pnx325
5. International Neuromodulation Society‡. Spinal cord stimulation’s role in managing chronic disease symptoms. Updated August 3, 2022. Accessed June 13, 2023. https://www.neuromodulation.com/spinal-cord-stimulation
6. Abbott. Proclaim™ SCS Implantable Pulse Generator Clinician’s Manual. 2023.
7. Abbott. Eterna™ SCS Implantable Pulse Generator Clinician’s Manual. 2023.
8. Abbott. Proclaim™ DRG Implantable Pulse Generator Clinician’s Manual. 2018.
9. Abbott. Data on File. DPN Pain Relief Comparison Memo (MAT-2308037). 2023.
10. Abbott. Eterna™ SCS IPG Size Comparison Memo (MAT-2210151). 2023.
11. 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. 2018;21(1):56-66. doi:10.1111/ner.12698
12. Abbott. Clinical Summaries for Spinal Cord Stimulation Systems Clinician’s Manual. 2023.
13. Huygen FJPM, Kallewaard JW, Nijhuis H, et al. Effectiveness and safety of dorsal root ganglion stimulation for the treatment of chronic pain: a pooled analysis. Neuromodulation. 2020;23(2):213-221. doi:10.1111/ner.13074
14. Deer TR, Levy RM, Kramer J, et al. Dorsal root ganglion stimulation yielded higher treatment success rate for complex regional pain syndrome and causalgia at 3 and 12 months: a randomized comparative trial.
Pain. 2017;158(4):669-681. doi:10.1097/j.pain.0000000000000814
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4
Neurostimulation therapy works by stimulating nerves along the spine or the dorsal root ganglion (DRG) using controlled electrical pulses to interfere with pain signals and alleviate pain.
The Proclaim™ Plus SCS System with FlexBurst360™ therapy is designed to give relief to people who feel pain in more than one area.
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6, 7
9
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