Expert review of medical devices
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The PRECICE(®) Intramedullary Limb Lengthening System (Ellipse Technologies Inc., CA, USA) is a remotely controlled, magnetically driven, implantable limb lengthening intramedullary nail system. It has both CE mark and US FDA clearance for its first- (2011) and second-generation (2013) implants. ⋯ It has been used worldwide in over 1000 cases. Its reported and published results in over 250 cases has been excellent with less pain and lower complication rates than with external fixation methods or previous implantable nail systems.
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Expert Rev Med Devices · May 2015
ReviewEvaluation of the eZono 4000 with eZGuide for ultrasound-guided procedures.
Ultrasound-guided procedures are increasingly common in a variety of acute care settings, such as the operating room, critical care unit and emergency room. However, accurate judgment of needle tip position using traditional ultrasound technology is frequently difficult, and serious injury can result from inadvertently advancing beyond or through the target. ⋯ The eZono 4000™ features an innovative needle navigation technology that is simple to use and permits the use of a wide range of commercially available needles, avoiding the inconvenience and cost of proprietary equipment. This article discusses this new ultrasound machine in the context of other currently available ultrasound machines featuring needle navigation.
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A mobile application (app) is a software program that runs on mobile communication devices such as a smartphone. The concept of a mobile medical app has gained popularity and diffusion but its reference regulatory context has raised discussion and concerns. Theoretically, a mobile app can be developed and uploaded easily by any person or entity. Thus, if an app can have some effects on the health of the users, it is mandatory to identify its reference regulatory context and the applicable prescriptions.
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Expert Rev Med Devices · May 2015
ReviewNeuromodulation in migraine: state of the art and perspectives.
Migraine is a highly prevalent and disabling disease. The drugs prescribed for migraine prophylaxis can have intolerable side effects or can be ineffective. Neuromodulation techniques are increasingly used in neurology. ⋯ These noninvasive therapies appear safe with a low rate of side effects. Available studies of invasive occipital nerve stimulation in chronic migraine gave modest results; but invasive occipital nerve stimulation offers a new hope to highly disabled patients who failed to respond to any other treatment. In the future, neuromodulation will probably take an increasing place in migraine treatment, as add-on therapy or alternative to medications, especially because of its attractive safety profile.
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Expert Rev Med Devices · Mar 2015
ReviewMimicking the brain: evaluation of St Jude Medical's Prodigy Chronic Pain System with Burst Technology.
The Prodigy is a new type of internal pulse generator that controls the delivery of electrical stimuli to nervous tissue. It is capable of delivering burst stimulation, which is a novel waveform that consists of closely spaced high-frequency electrical impulses delivered in packets riding on a plateau, and followed by a quiescent period. ⋯ As such, it is specifically capable of influencing the affective/attentional components of pain. Burst stimulation was initially safely applied off-label to the auditory cortex for tinnitus, and later also to the spinal cord, the somatosensory cortex for neuropathic pain, subcutaneously for failed back surgery syndrome, and cingulate cortex for addiction and tinnitus.