Vectors is a prospective, multicenter, single-arm study of targeted stimulation parameters in spinal cord stimulation (SCS) designed to evaluate the long-term efficacy of the therapy when the Evolve™ workflow is used.
Outcomes were assessed according to the following:
SCS screening trial success rate
90% of subjects experienced a successful screening trial (85% with HD stimulation).
of SCS screening trial patients had ≥ 50% reduction in pain.
Changes 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
Access to multiple therapy options1
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.
Improved functional capacity1
Function: As measured by the Oswestry disability index (ODI) at 3, 6, and 12 months
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
Function: As measured by individual patient activity goals3
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.
Function: As measured by Euro-QoL (EQ-5D) at 3, 6, and 12 months2,3
At 12 months, 77% of subjects were better on at least one dimension of the EQ-5D and no worse on any dimensions.
|EQ-5D change category||3 months||6 months||12 months|
|Health state is better: The EQ-5D is better on at least 1 dimension and is no worse in any other dimension.||75.5%||75.0%||76.9%|
|Health state is exactly the same: The EQ-5D is identical on all 5 dimensions.||2.0%||3.1%||1.1%|
|Changes in health are mixed: The EQ-5D is better on at least 1 dimension and is worse on at least 1 dimention.||21.4%||20.8%||20.9%|
|Health state is worse: The EQ-5D is worse on at least 1 dimension and is no better in any other dimension.||1.0%||1.0%||1.1%|
Patient global impression of change and satisfaction1
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.
Building long-term evidence for the Evolve™ workflow
Medtronic is invested in building long-term evidence for the Evolve™ workflow powered by Intellis™ with AdaptiveStim™ technology.
Vectors results powered by the Evolve™ workflow:
IF lead placement spans the T9/T10 space after mapping.
THEN consider the Evolve™ 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 optimize therapy for individual patients, which may require discontinuation or modification of a workflow.
Hatheway JA, Mangal V, Fishman MA, et al. Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study. Neuromodulation. 2021 Apr;24(3):556-565.
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.