Medtronic Enrolls First Patient in Pain Study to Assess Optimized Spinal Cord Stimulation Programming
January 09, 2018 at 05:30 pm IST
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Medtronic plc announced the first patient enrolled in the Vectors Post Market Clinical Study. The study will follow patients with chronic intractable pain who are undergoing spinal cord stimulation (SCS) treatment managed with the Evolve(SM) workflow, which standardizes guidance that balances high-dose (HD) and low-dose (LD) therapy settings to help physicians optimize treatment. Evolve runs on Medtronic SCS systems including Intellis(TM), the world's smallest implantable SCS neurostimulator, which recently received U.S. Food and Drug Administration and CE Mark approval. The first patient was enrolled by The Center for Interventional Pain & Spine in Wilmington, Delaware. The Vectors study is a prospective, multi-center, post-marketing study that will enroll up to 175 patients with chronic intractable pain of the low back and legs at up to 25 sites in the U.S. The study will assess SCS's long-term efficacy and impact on quality of life and was designed to provide evidence for the Evolve workflow by evaluating the effectiveness and potential patient benefits of having access to both HD and LD stimulation modalities. Patients will be followed for 12 months post implant. The Intellis platform offers important patient benefits. Using Medtronic's proprietary Overdrive(TM) battery technology, the Intellis platform can be fully recharged in approximately one hour, addressing a common patient complaint about the burden of recharging their implant. Physicians also get new tools, including Snapshot(TM), a software platform that tracks activity, body positions and therapy usage. This empowers physicians with objective insights about patient outcomes, like mobility and progress.
Medtronic plc is one of the world leaders in designing, manufacturing and marketing of medical equipment. Net sales break down by sector of activity as follows:
- general and minimally invasive surgery (28.8%): surgical equipment, intra-operative monitoring systems, ventilation systems, etc.;
- cardiac rhythm management (18.6%): implantable cardiac pacemakers, implantable defibrillators and automatic external defibrillators, cardiac ablation probes, etc.;
- vascular diseases and cardiac surgery (17.4%): coronary stents, endoprostheses for aortal pathologies, distal protection systems, catheters, heart valve prostheses, auto-transfusion equipment, cardiac ablation devices, etc.;
- spinal disorders (14.1%): spinal prostheses, disc prostheses, cerebral stimulation systems, bone graft technologies and mini-invasive spinal surgery, etc. The group also develops medical imagery-guided surgical navigation systems activity;
- neurovascular, ear, nose and throat (ENT) and pelvic diseases (8.2%);
- diabetes management (7.4%): internal and external glycemia monitoring systems and insulin pumps;
- neurological disorders (5.5%): neurostimulation and pumped medication administration products, diagnostic tools, etc.
Net sales are distributed geographically as follows: Ireland (0.3%), the United States (50.9%) and other (48.8%).