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Clinical Outcomes: Chronic Pain Targeted Drug Delivery

STUDIES CONFIRM EFFECTIVENESS

Pain Relief

  • Significant improvement in back and leg pain at 6 and 12 months (p < 0.001) compared to baseline1
  • In patients treated for at least 6 months (overall mean duration of 36.2 months), patients reported mean pain relief of 60%.2

Improved Function and Quality of Life

  • 87% of patients rated their quality of life as fair to excellent at 12 months1
  • 74% of patients reported increased activity levels (mean treatment duration of 36.2 months)2
  • 66% of patients had reduced disability at 12 months1

Patient Satisfaction and Reduction in Oral Medication

  • 88% of patients were satisfied with intrathecal therapy2
  • 90% of patients would recommend therapy to a family member or friend1
  • A retrospective claims analysis (n=389) found that 51 percent of chronic non-malignant pain patients eliminated systemic opioids within one year of TDD therapy. This elimination resulted in a 10% to 17% reduction in yearly inpatient, outpatient, and drug expenditures.3
  • A smaller, single-center, retrospective chart review (n=99) of patients with chronic non-malignant pain who agreed to transition from systemic opioids to TDD with the goal of eliminating systemic opioids, demonstrated that 84 percent of patients were able to eliminate systemic opioids after 12 months when using TDD to relieve their chronic pain.4

More Cost-effective Than Conventional Treatments

  • Evidence suggests that the cumulative future costs of intrathecal drug delivery may be less compared to conventional medical management (CMM).5,6
  • In one US study, the lifetime cost analysis indicated savings of $3,111 per patient per year for TDD compared to CMM.6
    • The lifetime financial benefit of TDD was attributed to: lower inpatient facility costs, reduced prescription expenses, as well as fewer ER visits, ambulatory surgeries, office visits, and adjunctive therapies.
1

Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain; report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5(1):6-13.

2

Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic noncancer pain. Eur J Pain. 2001;5(4):353-361.

3

Hatheway JA, Caraway D, David G, et al. Systemic opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health-care expenditures. Neuromodulation : journal of the International Neuromodulation Society. 2015;18(3):207-213.

4

Caraway D, Walker V, Becker L, Hinnenthal J. Successful Discontinuation of Systemic Opioids After Implantation of an Intrathecal Drug Delivery System. Neuromodulation : journal of the International Neuromodulation Society. 2015;18(6):508-516.

5

Kumar K, Hunter G, Demeria DD. Treatment of chronic pain by using intrathecal drug therapy compared with conventional pain therapies: a cost-effectiveness analysis. J Neurosurg. 2002;97(4):803-810.

6

Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Medicine. 2013;14:504-515.

Brief Statement

See the device manual for detailed information regarding the Instructions For Use, the implant procedure, indications, contraindications, warnings, precautions and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at 

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

If you have any questions specific to the medicinal product that you are using this device to administer, please contact the Marketing Authorisation Holder.

When ITB is mentioned, we are considering Intrathecal baclofen (an anti-spastic) administered by an intrathecal drug delivery pump therapy. Medtronic provides only the intrathecal drug delivery pump and the catheter; the intrathecal baclofen, morphine or ziconotide is provided by an external company.