CLINICAL OUTCOMES: VECTORS STUDY 3-MONTH RESULTS SPINAL CORD STIMULATION
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:
NOTE: Subjects will continue to be followed in the Vectors Study through 6- and 12-months post-implant.
90% of subjects experienced a successful screening trial (85% with HD stimulation).
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.
NOTE: With the VAS, patients rate level of pain on a scale from 0mm (no pain) to 100mm (worst possible pain).
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
96% of patients remained on HD therapy alone at three months post-implant with low dose (LD) therapy still an option.
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.
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
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.
81% of subjects reported satisfaction with SCS therapy.
91% of subjects would recommend SCS therapy to others.
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.
Vectors results powered by the Evolve workflow:
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 optimize therapy for individual patients, which may require discontinuation or modification of a workflow.
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.
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.
Teng J, Mekhail N. Neuropathic pain: mechanisms and treatment options. Pain Practice. 2003;3(1):8-21.
Fairbank JC, Couper J, Davies JB, O’Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66(8):271-273.