CLINICAL OUTCOMES: VECTORS STUDY 3-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.

Three-month 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 3-month visit.
  • Secondary Outcomes: The responder rate (defined as a ≥ 50% improvement in pain measured by the VAS) for overall, low-back, and leg pain at 3 months.
  • Additional Measures: Change in Oswestry Disability Index (ODI) and EuroQol (EQ-5D); subject satisfaction at 3-month visit compared to baseline. Subjects also identified an activity goal and were asked whether they achieved the goal at 2, 4, or 6 weeks or 3-months postimplant.

NOTE: Subjects will continue to be followed in the Vectors Study through 6- and 12-months post-implant.

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.

CHANGES IN PAIN

Clinically significant changes in pain were observed at 3-month follow-up.1,2 Improvements were observed in Overall Pain, Back Pain, and Leg Pain. A 45.8-point reduction was observed in overall pain. 

Graph showing the change in pain from baseline to 3 months in the Vectors study. A 45.8-point reduction in overall pain was observed.

NOTE: With the VAS, patients rate level of pain on a scale from 0mm (no pain) to 100mm (worst possible pain).

Graph showing responder rates at 3 months in the Vectors study.

NOTE: Responder rates are determined by a ≥ 50% reduction in pain. Responder rates are determined by the VAS scores which are graded and given a percentage score A 30% reduction in pain is clinically meaningful.3

ACCESS TO MULTIPLE THERAPY OPTIONS1,2

96% of patients remained on HD therapy alone at three months post-implant with low dose (LD) therapy still an option. 

Graph showing therapy use at 3 months follow-up. 96% 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 CAPACITY1,2

FUNCTION: AS MEASURED BY THE OSWESTRY DISABILITY INDEX (ODI) AT 6 AND 24 MONTHS

Graph showing functional capacity improvement as measured by Oswestry Disability Index (ODI).

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).4

FUNCTION: AS MEASURED BY INDIVIDUAL PATIENT ACTIVITY GOALS

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 SATISFACTION AND THERAPY RECOMMENDATION1,2

81% of subjects reported satisfaction with SCS therapy.

Graph showing subject satisfaction with spinal cord stimulation therapy. 81% of participants in the Vectors study reported satisfaction.

91% of subjects would recommend SCS therapy to others.

Graph showing percentage of Vectors study subjects who would recommend spinal cord stimulation therapy. 91% would recommend the therapy.

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. Subjects will be followed through 6- and 12-months post-implant.

 

Graphic showing how the Vectors study will follow subjects through 6 and 12 months post-implant.

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, Mangal V, Fishman M, et al. High Dose (HD) and Low Dose (LD) Spinal Cord Stimulation (SCS) for the effective treatment of Chronic Back and Leg Pain: Pain Responders. Poster presented at: American Society of Interventional Pain Physicians Annual Meeting; May 3-5, 2019; Las Vegas, NV.

2

Fishman M, Mangal V, Hatheway J, et al. High Dose (HD) and Low Dose (LD) Spinal Cord Stimulation (SCS) for the effective treatment of Chronic Back and Leg Pain: Improvements in Function. Poster presented at: American Society of Interventional Pain Physicians Annual Meeting; May 3-5, 2019; Las Vegas, NV.

3

Teng J, Mekhail N. Neuropathic pain: mechanisms and treatment options. Pain Practice. 2003;3(1):8-21.

4

Fairbank JC, Couper J, Davies JB, O’Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271-273.