Neuromodulation : journal of the International Neuromodulation Society
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Multicenter Study
Long-term follow-up of a novel implantable programmable infusion pump.
The Prometra® Programmable Pump System (Flowonix Medical, Inc., Mt. Olive, NJ, USA) is designed for continuous intrathecal administration of morphine sulfate to treat chronic intractable pain. As a follow-up to a previous report on acute six-month data, this study evaluated the efficacy of treatment at one year and the accuracy of drug delivery throughout the study (average of 2.5 years, range 0-3.6 years). ⋯ The Prometra pump demonstrated accurate drug delivery throughout the study and provides an effective and safe means for intrathecal administration of morphine sulfate for treatment of chronic intractable pain.
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Multicenter Study Clinical Trial
High-frequency spinal cord stimulation for the treatment of chronic back pain patients: results of a prospective multicenter European clinical study.
The objective of this prospective, open-label, multicenter European clinical trial was to quantify the efficacy and safety of a spinal cord stimulation (SCS) system that utilizes high-frequency (up to 10 kHz) waveforms, which do not produce paresthesia, for the treatment of chronic, intractable pain of the back and/or limbs. ⋯ In a cohort of patients with difficult-to-treat chronic back pain, high-frequency SCS provided significant and sustained low back pain and leg pain relief to more than 70% of treated subjects. Notably, this was achieved without paresthesia. Patients also experienced significant improvement in disability and sleep. Overall, the results confirm a favorable safety and efficacy profile of the high-frequency SCS system.
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Multicenter Study Clinical Trial
A prospective study of dorsal root ganglion stimulation for the relief of chronic pain.
The article aims to study the safety and effectiveness of dorsal root ganglion (DRG) stimulation with a new device in the treatment of chronic pain. ⋯ These initial results suggest that stimulation of the DRG can reduce pain in those patients suffering from chronic pain. DRG stimulation may offer several potential benefits over other neuromodulation techniques, including the ability to target difficult-to-reach anatomies such as the low back and foot.
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Randomized Controlled Trial Multicenter Study
Spinal cord stimulation therapy for patients with refractory angina who are not candidates for revascularization.
The aim of this study was to evaluate the safety and efficacy of spinal cord stimulation (SCS) for refractory angina. ⋯ Although this study was terminated early, the results obtained at six months suggest that SCS (HS) is not more effective than the control (LS) in patients with refractory angina.
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Multicenter Study Clinical Trial
Technological innovation in spinal cord stimulation: use of a newly developed delivery device for introduction of spinal cord stimulation leads.
The use of multiple cylindrical leads and multicolumn and single column paddle leads in spinal cord stimulation offers many advantages over the use of a single cylindrical lead. Despite these advantages, placement of multiple cylindrical leads or a paddle lead requires a more invasive surgical procedure. Thus, the ideal situation for lead delivery would be percutaneous insertion of a paddle lead or multiple cylindrical leads. This study evaluated the feasibility and safety of percutaneous delivery of S-Series paddle leads using a new delivery device called the Epiducer lead delivery system (all St. Jude Medical Neuromodulation Division, Plano, TX, USA). ⋯ This study suggests the safe use of the Epiducer lead delivery system for percutaneous implantation and advancement of the S-Series paddle lead in 34 patients.