Articles: surgery.
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The Food and Drug Administration (FDA) is classifying the focused ultrasound stimulator system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Review Meta Analysis
Pulmonary vein isolation with complex fractionated atrial electrogram ablation for paroxysmal and nonparoxysmal atrial fibrillation: A meta-analysis.
Pulmonary vein isolation (PVI) is recognized as a potentially curative treatment for atrial fibrillation (AF). Ablation of complex fractionated atrial electrograms (CFAEs) in addition to PVI has been advocated as a means to improve procedural outcomes, but the benefit remains unclear. ⋯ In these studies of patients with nonparoxysmal AF, addition of CFAE ablation to PVI results in greater improvement in freedom from AF. No additional benefit of this combined approach was observed in patients with paroxysmal AF.
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To compare intraoperative magnetic resonance imaging (MRI)-guided resection with resection guided by 5-aminolevulinic acid (5-ALA)-induced fluorescence in patients with gliomas and to evaluate the impact of intraoperative MRI in glioma surgery. ⋯ Intraoperative MRI-guided resection is a powerful tool to treat 5-ALA (-) gliomas (mostly low grade), and 5-ALA is useful for high-grade gliomas. The combination of intraoperative MRI and 5-ALA has a synergistic effect in glioma surgery. Additionally, precise tumor grading in preoperative imaging studies can be difficult. Surgery for gliomas should be performed using both 5-ALA-induced fluorescence and intraoperative MRI-guided resection.
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IEEE Trans Biomed Eng · Jul 2011
Randomized Controlled Trial Comparative StudyThe effect of augmented reality training on percutaneous needle placement in spinal facet joint injections.
The purpose of this study was to determine if augmented reality image overlay and laser guidance systems can assist medical trainees in learning the correct placement of a needle for percutaneous facet joint injection. The Perk Station training suite was used to conduct and record the needle insertion procedures. A total of 40 volunteers were randomized into two groups of 20. 1) The Overlay group received a training session that consisted of four insertions with image and laser guidance, followed by two insertions with laser overlay only. 2) The Control group received a training session of six classical freehand insertions. ⋯ The final insertion procedure was assessed to determine if there was a benefit to the overlay method compared to the freehand insertions. The Overlay group had a better success rate (83.3% versus 68.4%, p=0.002), and potential for less tissue damage as measured by the amount of needle movement inside the phantom (3077.6 mm(2) versus 5607.9 mm(2) , p =0.01). These results suggest that an augmented reality overlay guidance system can assist medical trainees in acquiring technical competence in a percutaneous needle insertion procedure.