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Indications, Safety and Warnings

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

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DTM™ SCS endurance therapy Spinal cord stimulation

DTM™ SCS endurance therapy is a spinal cord stimulation (SCS) therapy available to treat patients with chronic, intractable pain.

Download clinical results

DTM™ SCS endurance
therapy overview

Building on the foundation of Differential Target
Multiplexed™ (DTM) spinal cord stimulation (SCS),
DTM™ SCS endurance therapy is an energy modified
differential target multiplexed therapy offering
meaningful pain relief, satisfaction, and quality of
life improvements.1 This enables you to personalize
care for those seeking recharge-free longevity or
less frequent recharging.

Inspired by science

DTM™ SCS therapy options are inspired by decades of basic science research and preclinical understanding. In a preclinical study, the DTM™ programming (DTMP) derivatives modulated neuro-inflammatory processes more than low-rate SCS.*2

Clinical results show meaningful pain relief

Study objectives

DTM™ SCS endurance therapy study is a prospective, multicenter, single-arm study designed to evaluate the long-term efficacy and energy use of DTM™ SCS endurance therapy.1

Primary objective: To evaluate the effectiveness of DTM™ SCS endurance therapy in reducing overall pain intensity at 3-months follow up.

Secondary objectives with follow up to 12-months:

  • Characterize changes in pain intensity for overall, back, and leg pain
  • Characterize programming parameters associated with energy use
  • Characterize changes in functional disability as measured by Oswestry disability index (ODI)
  • Characterize subject satisfaction
  • Characterize therapy safety data

Study outcomes

Meaningful
pain relief

4.1

reduction in VAS for overall pain
from baseline to 6 months1

Meaningful and sustained pain relief at 6 months1

Overall pain

Meaningful quality of
life improvements

63%

of patients had minimal to moderate disability
at 3 months compared to only 16% at baseline1

Quality of life

Therapy satisfaction

75%

of patients are very or somewhat
satisfied with therapy1

Long lasting

5½-7½

years of recharge-free longevity
estimated using actual 6-month
programming data3

Save time

5 minutes

estimated daily rapid recharge
or recharge less frequently
(1 hour every 12 days)3

Superior
pain relief

DTM™ SCS offers proven pain relief backed by data on Intellis™ SCS. Learn about the therapy.4

See DTM™ SCS

Vanta™ SCS neurostimulator

High performance and recharge free. Experience DTM™ SCS endurance therapy on Vanta™.
 

Learn more

Intellis™ SCS neurostimulator 

Rapid recharge available with DTM™ SCS or DTM™ SCS endurance therapy. 
 

Discover Intellis™ SCS

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.

For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.

*Note: Data obtained from animal studies should not be extrapolated to clinical/human results.

1

Peacock, Provenzano, Fishman, et al. A prospective multi-center study of a differential target multiplexed™ stimulation derivative in therapy-naive patients. Poster presented at: International Neuromodulation Society (INS) World Congress; May 21-26, 2022; Barcelona, Spain.

2

Cedeno D, Vallejo R, Platt D, et al. Differential target multiplexed SCS using reduced energy parameters in an animal model of neuropathic pain. Poster presented at: American Society of Pain and Neuroscience (ASPN) annual meeting. July 22-25, 2021.

3

Provenzano, Amirdelfan, Grewal, et al. Modeling the impact of a differential target multiplexed derivative on rechargeable and recharge-free spinal cord stimulation systems using results from the Endurance Study. Poster presented at: International Neuromodulation Society (INS) World Congress; May 21-26, 2022; Barcelona, Spain.

4

Fishman M, Cordner H, Justiz R, et al.  12-Month Results from Multicenter, Open-Label, Randomized Controlled Clinical Trial Comparing Differential Target Multiplexed Spinal Cord Stimulation and Traditional Spinal Cord Stimulation in Subjects with Chronic Intractable Back Pain and Leg Pain. Pain Pract. 2021; 21: 912– 923.