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Diabetic Peripheral Neuropathy (DPN)

Woman sitting on a sofa looking down as she's massaging her leg
Discover how spinal cord stimulation treats chronic pain caused by diabetic peripheral neuropathy.

 

Published: June 2024

Author: ADCES staff

The following content is sponsored by Medtronic.

What is diabetic peripheral neuropathy?

Diabetic peripheral neuropathy (DPN): A neuropathy affecting the extremities, usually bilaterally, and is also often called distal symmetric polyneuropathy (DSP). The typical presentation is a “stocking and glove” distribution.1 When small nerve fibers are impacted (i.e., small fiber neuropathy), this sensorimotor neuropathy may cause pain and burning sensations, otherwise known as painful diabetic peripheral neuropathy. Large fiber neuropathy may cause loss of reflexes, paresthesia and impairment of touch and pressure sensation.2


What is spinal cord stimulation (SCS)?

SCS is a treatment for chronic pain through the modulation of the nerves that help control pain. SCS is delivered by sending electrical pulses from a neurostimulator through a lead to the spinal cord to modulate pain signals. For the trial procedure, temporary leads are placed near the spinal cord and connected to an external stimulator. The patient evaluates the therapy for approximately one week. If the trial is successful, a complete neurostimulation system can be implanted. This system includes a neurostimulator, extensions and leads. The patient can control the therapy with a patient controller, and a recharging system is required for rechargeable neurostimulators. A Medtronic implantable spinal cord stimulation (SCS) device serves as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with diabetic peripheral neuropathy (DPN) of the lower extremities.


Spinal Cord Stimulation Platforms

For patients who experience chronic pain due to painful diabetic peripheral neuropathy (DPN) and have not been satisfied by the levels of relief provided by oral pain medication, creams or ointments, or other pain treatments, Medtronic's spinal cord stimulation (SCS) platforms Intellis™, Inceptiv™ and Vanta™ deliver a non-opioid, FDA-approved way to manage chronic pain that may be caused by painful DPN. SCS works by disrupting the pain signals traveling between the spinal cord and the brain.

Front & side view of Medtronic Intellis implantable spinal cord neurostimulator

 

   Intellis™ Platform - Spinal Cord Stimulation

 
Details:

Intellis™ is a thin implantable spinal cord neurostimulator, < 1 hour recharge - empty to full (approximate time), designed for patient comfort and more flexible placement during implant.

Trial:

The Medtronic SCS trial system lets you and your patient "test drive" how SCS therapy may improve their daily activities without requiring the SCS device to be implanted.

MRI Access:
Medtronic SCS systems provide unmatched full-body MRI access that provides patients the same access as non-implanted patients now and in the future. MR Safety Triangle Under specific conditions. Refer to product labeling for full list of conditions.
Approved for Children:
No
Battery Size:
Height: 57.1 mm/2.2 in 
Width: 47.22 mm/1.9 in
Volume 13.9cc
Battery Life:
Intellis™ is a rechargeable device that offers 95% capacity at 9 years.

 


Front & side view of Medtronic Vanta recharge-free spinal cord neurostimulator

Vanta™ Platform - Spinal Cord Stimulation

 
Details:

Vanta™ is a high-performance recharge-free spinal cord neurostimulator that lasts ~2x longer than other devices at comparable settings.†‡

† Settings from Boston Scientific's Alpha™ IFU. Programmed at 4.1mA, 280us. 40Hz. 1 area, 730 Ohms, 2 contacts.
‡ Settings used from Proclaim™ clinician manual. Nominal settings 12 hours per day: 50-Hz frequency. 225-μs pulse width, and 5-mA amplitude at 500-ohms impedance. Energy modeling is the same for model 3660 and model 3670.
Trial:
The Medtronic SCS trial system lets you and your patient "test drive" how SCS therapy may improve their daily activities without requiring the SCS device to be implanted.
MRI Access:
Medtronic SCS systems provide unmatched full-body MRI access, that provides patients the same access as non-implanted patients now and in the future. MR Safety Triangle Under specific conditions. Refer to product labeling for full list of conditions.
Approved for Children:
No.
Battery Size:
Height: 68 mm/2.67 in 
Width: 51 mm/2.00 in
Volume 33 cc
Battery Life:
5½–7½ years of recharge-free longevity estimated using actual 12-month DTM™ SCS endurance therapy programming data.1  

Provenzano, Amirdelfan, Grewal, et al. Modeling energy demands of a reduced-energy derivative of DTM™ stimulation on rechargeable and recharge-free SCS systems. Poster presented at: American Society of Regional Anesthesia and Pain Medicine (ASRA) Annual Pain Medicine Meeting; Nov. 17–19, 2022; Orlando, FL, USA

 


Front & side view of Medtronic Inceptiv advanced SCS system with automatic closed-loop sensing technology

    Inceptiv™ Platform - Spinal Cord Stimulation

 
Details:

Inceptiv™ is the most advanced SCS system with automatic closed-loop sensing† technology, the best full body 1.5T and 3T MRI access‡ and the smallest and thinnest SCS device.

† Sensing signals may not be measurable in all cases.
‡ MR Safety Triangle Under specific conditions. Refer to product labeling for full list of conditions.
Trial:
The Medtronic SCS trial system lets you and your patient "test drive" how SCS therapy may improve their daily activities without requiring the SCS device to be implanted.
MRI Access:
Medtronic SCS systems provide unmatched full-body MRI access, that provides patients the same access as non-implanted patients now and in the future. MR Safety Triangle Under specific conditions. Refer to product labeling for full list of conditions.
Approved for Children:
No.
Battery Size:
Height: 57 mm/2.2 in 
Width: 47 mm/1.9 in
Volume 13.77cc
Battery Life:

Inceptiv™ is a rechargeable device with an expected lifetime of 15 years before elective replacement indicator is activated.

 

SCS Coverage & Safety Information

Covered by Medicare:
Yes, SCS for painful DPN is universally covered by Medicare.
Commercial Coverage:
Commercial coverage is variable. Reach out to Medtronic's Reimbursement Team and Medtronic's Patient Access Portal.
Safety Information:

Spinal Cord Stimulation Brief Summary: INDICATIONS Spinal cord stimulation (SCS) is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. CONTRAINDICATIONS Diathermy - Energy from diathermy can be transferred through the implanted system and cause tissue damage resulting in severe injury or death. WARNINGS Sources of electromagnetic interference (e.g., defibrillation, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact with the system, resulting in unexpected changes in stimulation, serious patient injury or death. An implanted cardiac device (e.g., pacemaker, defibrillator) may damage a neurostimulator, and electrical pulses from the neurostimulator may cause inappropriate response of the cardiac device. Patients with diabetes may have more frequent and severe complications with surgery. A preoperative assessment is advised for some patients with diabetes to confirm they are appropriate candidates for surgery. PRECAUTIONS Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. Avoid activities that put stress on the implanted neurostimulation system components. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site. ADVERSE EVENTS May include: undesirable change in stimulation (uncomfortable, jolting or shocking); hematoma, epidural hemorrhage, paralysis, seroma, infection, erosion, device malfunction or migration, pain at implant site, loss of pain relief, and other surgical risks. Adverse events may result in fluctuations in blood glucose in patients with diabetes. Refer to www.medtronic.com for product manuals for complete indications, contraindications, warnings, precautions and potential adverse events. Rx only. Rev 0422

 

Learn More About Treating Diabetic Neuropathy on The Huddle Podcast

Addressing Painful Diabetes-Related Neuropathy in Practice

A New Therapy Option for Managing Painful Diabetic Peripheral Neuropathy (DPN)


References:

1. Feldman EL, Callaghan BC, Pop-Busui R, et al. Diabetic neuropathy. Nat Rev Dis Primers. 2019 Jun 13;5(1):42.

2. Singh R, Rao HK, Singh TG. Neuropathic pain in diabetes mellitus: Challenges and future trends. Obesity Medicine. 2020 Vol 18.

Spinal Cord Stimulation

Watch a detailed overview to discover how it works:

SCS Therapy & Surgical Procedure 

Explore SCS Further

For additional questions about spinal cord stimulation:

Speak with a Medtronic Representative

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DISCLAIMERS: 

This site and its services do not constitute the practice of medical advice, diagnosis or treatment. Always talk to your diabetes care and education specialist or health care provider for diagnosis and treatment, including your specific medical needs. If you have or suspect that you have a medical problem or condition, please contact a qualified health care professional immediately. To find a diabetes care and education specialist near you, visit the ADCES finder tool.

ADCES and danatech curate product specifics and periodically review them for accuracy and relevance. As a result, the information may or may not be the most recent. We recommend visiting the manufacturer's website for the latest details if you have any questions.

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