In The Lupe

References

Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

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.

Deer T, et al. The Neuromodulation Appropriateness Consensus Committee on best practices for dorsal root ganglion stimulation. Neuromodulation. 2018;22(1):1-35.

Kemler, M., Barendse, G., Kleef, M., Vet, H., Rijks, C., Furnée, C., Wildenberg, F. (2000). Spinal Cord Stimulation in Patients with Chronic Reflex Sympathetic Dystrophy The New England Journal of Medicine 343(9), 618-624. https://dx.doi.org/10.1056/nejm200008313430904

Harden RN, Bruehl S, Perez RS, et al. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010;150(2):268-274. doi:10.1016/j.pain.2010.04.030

North, R., Kidd, D., Farrokhi, F., Piantadosi, S. (2005). Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial Neurosurgery 56(1), 98-107. https://dx.doi.org/10.1227/01.neu.0000144839.65524.e0

Deer T, et al. The Neuromodulation Appropriateness Consensus Committee on best practices for dorsal root ganglion stimulation. Neuromodulation. 2018;22(1):1-35.

Jude Medical™ Proclaim™ Neurostimulation System Clinician’s Manual. Plano, TX 2018

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.

Stauss T, et al. A multicenter real-world review of 10 kHz SCS outcomes for treatment of chronic trunk and/or limb pain. Annals of Clinical and Translational Neurology. 2019. doi:10.1002/acn3.720.

 

* Up to 10 years of battery longevity at the lowest dose setting: 0.6mA, 500 Ohms, duty cycle 30s on/360s off. NOTE: In neurostimulation therapy, “dose” refers to the delivery of a quantity of energy to tissue. Safety comparisons and specific dose-response curves for each dosage have not been clinically established. Refer to the IFU for additional information.Hassle-free means recharge-free.

** When compared to traditional tonic stimulation.

***at 22:25 Speakers are referring to causalgia, not peripheral causalgia, this is defined in the ISI, see below

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

DRG

Indications for Use:

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

International: Management of chronic intractable pain.

Contraindications:

US: Patients

Learn the history of neurostimulation, the reason Abbott’s portfolio was designed in partnership with physicians, and why Drs. Timothy Lubenow and Jason Pope had an Abbott epiphany. This new podcast series was designed to help you transition from a fellowship to practice

References

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.

 

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications for Use: US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

Contraindications: US: Patients who are unable to operate the system, who are poor surgical risks, or who have failed to receive effective pain relief during trial stimulation.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, pediatric use, pregnancy, and case damage.

Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). User’s Guide must be reviewed for detailed disclosure.

 

AbbottOne St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000Neuromodulation.Abbott

™ Indicates a trademark of the Abbott group of companies.‡ Indicates a third party trademark, which is property of its respective owner.© 2020 Abbott. All Rights Reserved.

MAT-2005387 v1.0 | Item approved for Global use.

A podcast for pain fellows covering topics that help you transition from fellowship to practice and give you the insight you need for real-world medicine. This episode introduces our hosts and shares insights on their pain medicine fellowship experiences. Please see our important safety information here https://www.neuromodulation.abbott/us/en/important-safety-info.html

References

Proclaim™ DRG Neurostimulation System Clinician’s Manual. Plano, TX. 2018.

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.

Deer T, et al. The Neuromodulation Appropriateness Consensus Committee on best practices for dorsal root ganglion stimulation. Neuromodulation. 2018;22(1):1-35.

Kemler, M., Barendse, G., Kleef, M., Vet, H., Rijks, C., Furnée, C., Wildenberg, F. (2000). Spinal Cord Stimulation in Patients with Chronic Reflex Sympathetic Dystrophy The New England Journal of Medicine 343(9), 618-624. https://dx.doi.org/10.1056/nejm200008313430904

Harden RN, Bruehl S, Perez RS, et al. Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome. Pain. 2010;150(2):268-274. doi:10.1016/j.pain.2010.04.030

 North, R., Kidd, D., Farrokhi, F., Piantadosi, S. (2005). Spinal Cord Stimulation versus Repeated Lumbosacral Spine Surgery for Chronic Pain: A Randomized, Controlled Trial Neurosurgery 56(1), 98-107. https://dx.doi.org/10.1227/01.neu.0000144839.65524.e0

 

Rx OnlyBrief Summary: Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system.

Indications for Use: US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study.

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia).

Contraindications: US: Patients who are unable to operate the system, who are poor surgical risks, or who have failed to receive effective pain relief during trial stimulation.

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, pediatric use, pregnancy, and case damage.

Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). User’s Guide must be reviewed for detailed disclosure.

 

Abbott One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 Neuromodulation.Abbott

™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party tradema