Expert review of medical devices
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Expert Rev Med Devices · Nov 2014
ReviewPercutaneous endoscopic decompression for lumbar spinal stenosis.
Percutaneous endoscopic lumbar discectomy has become a representative minimally invasive spine surgery for lumbar disc herniation. Due to the remarkable evolution in the techniques available, the paradigm of spinal endoscopy is shifting from treatments of soft disc herniation to those of lumbar spinal stenosis. ⋯ However, these techniques are continuously evolving. In the near future, PED for lumbar stenosis may be an efficient alternative to conventional open lumbar decompression surgery.
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Expert Rev Med Devices · Nov 2014
ReviewThe RNS System: responsive cortical stimulation for the treatment of refractory partial epilepsy.
The RNS(®) System is the first commercially available device to provide closed-loop responsive brain stimulation. The system includes a cranially implanted neurostimulator that continually monitors the electrocorticogram through one or two depth and/or subdural cortical strip leads that are placed at the seizure focus. ⋯ Safety and effectiveness of the RNS System for the indicated patient population was demonstrated in a multicenter, randomized, sham-stimulation controlled 2-year pivotal study. An ongoing, prospective, long-term treatment study is currently gathering an additional 7 years of prospective safety and effectiveness data of the RNS System.
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Expert Rev Med Devices · Sep 2014
ReviewThe lung volume reduction coil for the treatment of emphysema: a new therapy in development.
Lung volume reduction (LVR) coil treatment is a novel therapy for patients with severe emphysema. In this bilateral bronchoscopic treatment, approximately 10 LVR coils per lobe are delivered under fluoroscopic guidance in two sequential procedures. The LVR coil reduces lung volume by compressing the most destructed areas of the lung parenchyma and restores the lung elastic recoil. ⋯ The LVR-coil treatment has been evaluated in several European clinical trials since 2008 and received CE mark approval in 2010. Currently, two large multicenter randomized controlled trials are underway in Europe and North America to assess the efficacy and safety of the LVR-coil treatment at 12 months compared with usual care. In this review, we share our experience with the LVR-coil treatment.
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Expert Rev Med Devices · Sep 2014
ReviewNew autoinjector technology for the delivery of subcutaneous methotrexate in the treatment of rheumatoid arthritis.
Methotrexate (MTX) is the cornerstone of treatment for rheumatoid arthritis (RA), and is widely used both as first-line therapy and as an important component of long-term therapy. Although subcutaneous MTX is typically delivered orally, parenteral administration offers benefits with respect to tolerability and systemic exposure, and may be an underutilized treatment option. ⋯ A novel MTX autoinjector (MTXAI) was recently introduced, which is designed to facilitate subcutaneous MTX self-administration among patients with RA. Here we review the development and utility of the MTXAI in the treatment of RA, and discuss how this technology may facilitate the use of subcutaneous MTX.
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Expert Rev Med Devices · Jul 2014
ReviewHemodynamic impact of cerebral aneurysm endovascular treatment devices: coils and flow diverters.
Coils and flow diverters or stents are devices successfully used to treat cerebral aneurysms. Treatment aims to reduce intra-aneurysmal flow, thereby separating the aneurysmal sac from the blood circulation. ⋯ Summarizing findings on hemodynamic impact of treatment devices, we conclude: coiling and stenting do not affect post-treatment intra-aneurysmal pressure, but significantly alter aneurysmal hemodynamics through flow reduction and a change in flow structure. The impact of treatment devices on aneurysmal flow depends, however, on a set of parameters including device geometry, course of placement, parent vessel and aneurysm geometry.