A new therapy option for managing painful diabetic peripheral neuropathy (DPN)
This episode is sponsored by Medtronic.
Painful diabetic peripheral neuropathy (DPN) can significantly impact a person with diabetes and their quality of life. Nalani Hunsaker PA-C, MCMSc, BC-ADM, a paid consultant for Medtronic, joins The Huddle to talk about Medtronic’s spinal cord stimulation therapy option, how the procedure works, and its success in relieving pain from DPN. Please reach out to http://www.medtronic.com/dpnconnect to connect with a Medtronic representative today. If you would like to share more information with your patients check out http://www.medtronic.com/dpnpain
References:
1. de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicentre randomized clinical trial. Pain. 2014;155(11):2426–2431. doi:10.1016/j.pain.2014.08.031
2. Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: A prospective two-center randomized controlled trial. Diabetes Care. 2014;37(11):3016–3024. doi:10.2337/dc14-0684
3. Medtronic Pain Therapy Clinical Summary M221494A016 Rev B. United States; 2022.
4. van Beek M, Geurts JW, Slangen R, et al. Severity of neuropathy is associated with long-term spinal cord stimulation outcome in painful diabetic peripheral neuropathy: Five-year follow-up of a prospective two-center clinical trial. Diabetes Care. 2018;41(1):32–38. doi:10.2337/dc17-0983
5. Zuidema X et al. Long-term Evaluation of Spinal Cord Stimulation in Patients With Painful Diabetic Polyneuropathy: An Eight-to-Ten-Year Prospective Cohort Study. Neuromodulation. 2022 Dec 30:S1094-7159(22)01403-9.
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7. Desai MJ, Hargens LM, Breitenfeldt MD, Doth AH, Ryan MP, Gunnarsson C, Safriel Y. The rate of magnetic resonance imaging in patients with spinal cord stimulation. Spine (Phila Pa 1976). 2015 1;40(9):E531-7.
8. Mullins CF, Harris S, Pang D. A retrospective review of elevated lead impedances in impedance-dependent magnetic resonance-conditional spinal cord stimulation devices. Pain Pract. 2023;00:1–8 https://creativecommons.org/licenses/by/4.0/.
9. Temel Y, Ackermans L, Celik H, et al. Management of hardware infections following deep brain stimulation. Acta Neurochir (Wien). April 2004;146(4):355-361.
10. Pepper J. Zrinzo L, Mirza B, Foltynie T, Limousin P, Hariz M. The risk of hardware infection in deep brain stimulation surgery is greater at impulse generator replacement than at the primary procedure. Stereotact Funct Neurosurg. 2013;91(1):56-65.
11. Tolleson C, Stroh J, Ehrenfeld J, Neimat J, Konrad P, Phibbs F. The factors involved in deep brain stimulation infection: a large case series. Stereotact Funct Neurosurg. 2014;92(4): 227-233.
12. Thrane JF, Sunde NA, Bergholt B, Rosendal F. Increasing infection rate in multiple implanted pulse generator changes in movement disorder patients treated with deep brain stimulation. Stereotact Funct Neurosurg. 2014;92(6):360-364.
13. Deer TR, Provenzano DA, Hanes M, et al. The Neurostimulation Appropriateness Consensus Committee (NACC) Recommendations for Infection Prevention and Management [published correction appears in Neuromodulation. July 2017;20(5):516]. Neuromodulation. January 2017;20(1):31-50.
14. Mekhail NA, Mathews M, Nageeb F, Guirguis M, Mekhail MN, Cheng J. Retrospective review of 707 cases of spinal cord stimulation: indications and complications. Pain Pract. March-April 2011;11(2):148-153.
15. Falowski SM, Provenzano DA, XIa Y, Doth AH. Spinal Cord Stimulation Infection Rate and Risk Factors: Results From a United States Payer Database. Neuromodulation. February 2019;22(2):179-189.
16. Clifton M, Quirouet A, Pizarro-Berdichevsky J, et al. Infection rate after sacral neuromodulation surgery: a review of 1033 InterStim procedures. J Urol. April 2016;195(4S):851.
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21. Bendel MA, O’Brien T, Hoelzer BC, et al. Spinal Cord Stimulator Related Infections: Findings From a Multicenter Retrospective Analysis of 2737 Implants. Neuromodulation. August 2017;20(6):553-557.
22. Wexner SD, Hull T, Edden Y, et al. Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg. July 2010;14(7):1081-1089.15
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27. Tarakji KG, Mittal S, Kennergren C, et al. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. N Engl J Med. May 16, 2019;380(20):1895-1905
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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
TYRX™ Neuro Absorbable Antibacterial Envelope Brief Statement
The TYRX™ Neuro Absorbable Antibacterial Envelope is intended to hold a vagus nerve stimulator, a spinal cord neuromodulator, a deep brain stimulator or a sacral nerve stimulator securely in order to create a stable environment when implanted in the body. The Neuro Antibacterial Envelope contains the antimicrobial agents Minocycline and Rifampin which, have been shown to reduce infection in an in vivo model of bacterial challenge following surgical implantation of a pulse generator. The Neuro Antibacterial Envelope is NOT indicated for use in patients who have an allergy or history of allergies to tetracyclines, Rifampin, or absorbable sutures. The Neuro Antibacterial Envelope is also NOT indicated for use in patients with contaminated or infected wounds, or Systemic Lupus Erythematosus (SLE). This device is intended to be used in conjunction with vagus nerve stimulators or deep brain stimulators implanted in the infraclavicular fossa, or in conjunction with spinal cord neuromodulators or sacral nerve stimulators implanted laterally to the body midline and slightly superior to the gluteal region. The use of this product in patients with compromised hepatic and renal function, or in the presence of hepatotoxic or renal toxic medications, should be considered carefully, because Minocycline and Rifampin can cause additional stress on the hepatic and renal systems. Patients who receive the Neuro Antibacterial Envelope and who are also taking methoxyflurane should be monitored carefully for signs of renal toxicity.
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