Medtronic announces primary endpoint results of Vectors study
Medtronic announced primary endpoint results of the Vectors post market clinical study that demonstrated pain relief and improved function in patients with chronic intractable back and leg pain treated with spinal cord stimulation, or SCS, utilizing the EvolveSM workflow. Medtronic offers the Evolve workflow to help physicians balance high-dose, or HD, and low-dose, or LD, therapy settings on Medtronic SCS systems, including the Intellis platform. Results were presented at the American Society of Interventional Pain Physicians, or ASIPP, annual meeting and found that patients experienced a statistically significant and clinically meaningful improvement with 69% of patients experiencing greater than 50% improvement in overall pain and 70% achieving a personal activity goal at three months. Ninety percent of study subjects had a successful screening trial. One-hundred-three were then implanted with the device, and 98 patients completed the primary endpoint visit. Data from the study demonstrated sustained pain relief, improved quality of life and decreased disability after device implant. Overall: 69% of patients had at least a 50% improvement in overall pain, 70% of patients achieved a personal activity goal, 81% of patients were satisfied with their therapy and 65% improved at least one disability category in the Oswestry Disability Index. The prospective, single-arm, multicenter Vectors study was designed to provide evidence for the Evolve workflow by assessing the effectiveness and potential patient benefits of SCS while having access to both HD and LD stimulation modalities.