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Vectors is a prospective, multicentre, single-arm study of targeted stimulation parameters in spinal cord stimulation (SCS) designed to evaluate the long-term efficacy of the therapy when the EvolveSM workflow is used.
Outcomes were assessed according to the following:
90% of subjects experienced a successful screening trial (85% with HD stimulation).
of SCS screening trial patients had ≥ 50% reduction in pain.
Statistically significant pain relief was achieved at three months follow up. Clinically significant and sustained pain relief was observed for overall pain, back pain and leg pain at 12-month follow-up.
Note: Pain relief was measured using patient-reported pain using VAS (scale 0mm - no pain, to 100mm - worst possible pain).
*Overall Pain n=90
At 12 months post-implant, 95% of patients remained on HD therapy with low dose (LD) therapy still an option. Importantly, 5% of patients were benefiting from maintained access to LD stimulation.
NOTE: The effectiveness of low dose stimulation has been well established in multiple clinical studies. With the increasing use of HD stimulation, Vectors provides additional evidence for the use of HD and LD stimulation.
At 12 months, 76% of subjects had improved in at least one ODI category.
NOTE: The ODI score is produced from patient-completed questionnaires that include six statements in each of 10 sections concerning impairments like pain and abilities such as personal care, lifting, reading, driving, and recreation. The scale is interpreted as: 0%–20% (minimal disability); 20%–40% (moderate disability); 40%–60% (severe disability); 60%–80% (severely disabled in several areas of life/crippled); 80%–100% (bed bound or exaggerating symptoms).3
70% of patients had achieved a personal activity goal by three months post-implant.
NOTE: Each patient set an individual and specific activity goal that was important to them at the beginning of the study. Once patients achieved an activity goal, a new goal was set for future follow-up. Patient goals were only collected and assessed through the 3 month follow up visit.
At 12 months, 77% of subjects were better on at least one dimension of the EQ-5D and no worse on any dimensions.
At 12-month follow-up, 86% of subjects rated themselves as “Somewhat better” to “A great deal better.”
Satisfaction with Intellis SCS increased from 80% at 3 months to 85% at 12-month follow-up.
Medtronic is invested in building long-term evidence for the Evolve workflow powered by Intellis™ with AdaptiveStim™ technology.
IF lead placement spans the T9/T10 space after mapping.
THEN consider the EvolveSM workflow deliberate dose strategy, using both HD and LD.
DILIGENT PATIENT FOLLOW-UP TO ASSESS FOR OPTIMAL PROGRAMMING
A workflow is guidance only. Physicians should use their medical judgment and product labelling to optimise therapy for individual patients, which may require discontinuation or modification of a workflow.
Hatheway J, Fishman M, Mangal V et al. Vectors Post Market Study: Pain relief outcomes using spinal cord stimulation with high dose stimulation parameters. Presentation at NANS 2020, Las Vegas, Nevada.
Fishman M, Davies L, Stromberg K et al. Vectors Post Market Study: SCS (HD) trialing duration and 12-Month Pain Relief following trial success. Presentation at NANS 2020, Las Vegas, Nevada.
Hatheway J, Fishman M, Mangal V et al. Vectors Post Market Study: Functional outcomes using spinal cord stimulation with high dose stimulation parameters. Presentation at NANS 2020, Las Vegas, Nevada.
See the device/therapy manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events, If using an MRI SureScanTM device, see the MRI SureScanTM technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.