Expert review of medical devices
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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
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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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.
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Expert Rev Med Devices · Jan 2015
ReviewThe Silk flow-diverter stent for endovascular treatment of intracranial aneurysms.
Flow diverter (FD) stents represent a new endovascular technique developed for the treatment of complex intracranial aneurysms (wide neck, fusiform, large, and giant aneurysms) that are challenging for classic endovascular techniques such as coiling, balloon-assisted coiling and stent-assisted coiling. Low porosity, high metal coverage, and high pore density are the main properties of FD stents. These properties induce hemodynamic changes redirecting the blood flow away from the aneurysm and into the parent artery leading to gradual thrombosis of the aneurysm. ⋯ This is considered as a paradigm shift compared to prior endovascular methods, which predominantly aimed at providing treatment inside the aneurysmal sac. This paper describes in detail the first released FD stent, the Silk flow-diverter stent (Balt Extrusion, Montmorency, France), its mechanism of action and deployment technique. It reviews the pertinent literature regarding safety, efficacy and potential risks and complications associated with the use of this stent.
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Expert Rev Med Devices · Jan 2015
ReviewOutcomes of post-operative periprosthetic femur fracture around total hip arthroplasty: a review.
As the number of primary total hip arthroplasties increase over the next several decades so will the incidence of periprosthetic fractures around the femoral stem. Treatment can reliably be predicted using the Vancouver classification with internal fixation being indicated in fractures involving a stable implant and revision arthroplasty indicated in those with unstable prostheses. ⋯ The treatment of Vancouver C periprosthetic fractures continues to follow basic AO fixation principles with an emphasis on eliminating stress risers with adequate implant overlap and length. This review will focus on the risk factors and classification of these fractures, as well as highlight the treatment options for post-operative periprosthetic femoral fractures around a total hip arthroplasty.