CLINICAL OUTCOMES: VECTORS STUDY 12‑MONTH RESULTS SPINAL CORD STIMULATION

VECTORS STUDY

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 EvolveSM workflow is used.

  • Population: patients with chronic intractable low-back and leg pain
  • Sample Size: Baseline for the study was 103 patients. 98 patients completed a three month post-implant follow-up visit, 96 at six months, and 91 patients at 12 months.
  • Centers: 20 sites in the United States
  • Device: The Intellis™ platform with AdaptiveStim™ technology

Outcomes were assessed according to the following:

  • Primary Outcome Measurement: Demonstrate a significant improvement in overall pain intensity using high dose (HD) stimulation starting at (90/1000) targeting T9/T10 disc space as measured by visual analogue scale (VAS) from baseline to a three-month visit.
  • Secondary Pain Outcomes (3-, 6-, and 12-month follow-ups):
    • Pain relief as measured by change in VAS (0-100) for overall, low-back, and leg pain.
    • The responder rate (defined as a ≥ 50% improvement in pain measured by the VAS) for overall, low-back, and leg pain.
  • Additional Outcomes  (3-, 6-, and 12-month follow-ups):
    • Change in Oswestry Disability Index (ODI)
    • Change in EuroQol (EQ-5D)
    • Personal goal achievement (3 months only) 
    • Therapy satisfaction
    • Patient Global Impression of Change (PGIC)

SCS SCREENING TRIAL SUCCESS RATE

90% of subjects experienced a successful screening trial (85% with HD stimulation).

Graphic showing the Vectors study 90% success rate.

90%

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).

Graph showing the change in average VAS from baseline to 12 months. Average VAS dropped approximately 30 percentage points.

*Overall Pain n=90

ACCESS TO MULTIPLE THERAPY OPTIONS2

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.

Graph showing therapy use at 12 months follow-up. 95% of patients in Vectors study remained on high dose SCS therapy.

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 CAPACITY2,3

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.

Graph showing functional capacity improvement as measured by Oswestry Disability Index (ODI) at baseline, 3 months, 6 months, and 12 months.

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.

Graph showing functional capacity improvement as measured by individual patient activity goals.

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.

Graph showing Euro-QoL (EQ-5D) results at 3, 6, and 12 months post-implant. 77% of subjects were better on at least one dimension of the EQ-5D and no worse on any dimensions.

PATIENT GLOBAL IMPRESSION OF CHANGE AND SATISFACTION2,3

At 12-month follow-up, 86% of subjects rated themselves as “Somewhat better” to “A great deal better.”

Graph showing patient global impression of change. 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.

Graph showing subject satisfaction with spinal cord stimulation therapy. Satisfaction with Intellis SCS increased from 80% at 3 months to 85% at 12-months 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:

1

IF lead placement spans the T9/T10 space after mapping.

THEN consider the EvolveSM workflow deliberate dose strategy, using both HD and LD.

2

The suggested dose sequence begins with predefined HD settings.

The words HD and LD written in white text on blue backgrounds

3

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.

1

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.

2

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.

3

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.