Expert review of medical devices
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Expert Rev Med Devices · Jul 2011
ReviewRationale, design and clinical performance of the Superion® Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis.
Lumbar spinal stenosis is a progressive degenerative condition that manifests as low back pain with neurogenic claudication as a cardinal clinical feature. Although mild radicular symptoms can often be successfully treated with conservative care, management of lumbar spinal stenosis grows increasingly difficult as symptoms worsen. No satisfactory nonsurgical treatments exist to manage moderate radicular symptoms and, therefore, these patients are faced with the decision of continuing ineffective conservative options or opting to undergo invasive decompressive spine surgery. ⋯ The Superion device is a titanium implant that is delivered percutaneously and deployed between the spinous processes at the symptomatic vertebral levels. The Superion device improves radicular symptoms by limiting spinal extension and, consequently, minimizing impingement of neural and vascular elements. This article describes the rationale for and the design of the Superion device and summarizes initial clinical results with this novel, minimally invasive interspinous spacer.
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Expert Rev Med Devices · Mar 2011
ReviewState of the art in hard-on-hard bearings: how did we get here and what have we achieved?
Total hip arthroplasty has shown excellent results in decreasing pain and improving function in patients with degenerative disease of the hip. Improvements in prosthetic materials, designs and implant fixation have now resulted in wear of the bearing surface being the limitation of this technology, and a number of hard-on-hard couples have been introduced to address this concern. The purpose of this article is to review the origins, development, survival rates and potential advantages and disadvantages of the following hard-on-hard bearings for total hip arthroplasty: metal-on-metal standard total hip arthroplasty; metal-on-metal hip resurfacing arthroplasty, ceramic-on-ceramic total hip arthroplasty; and ceramic-on-metal bearings. ⋯ Contemporary ceramic-on-metal interfaces are in the early stages of clinical use, with little data reported to date. Hard-on-hard bearings for total hip arthroplasty have improved dramatically over the past 50 years. As bearing designs continue to improve with new and modified materials and improved manufacturing techniques, it is likely that the use of hard-on-hard bearings will continue to increase, especially in young and active patients.
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Expert Rev Med Devices · Mar 2011
Autofluorescence imaging videobronchoscopy in the detection of lung cancer: from research tool to everyday procedure.
Autofluorescence imaging videobronchoscopy (AFI) is one of the new systems of autofluorescence bronchoscopy designed for thorough examination of bronchial mucosa. The integration of autofluorescence and videobronchoscopy provides clear images of normal and pathologically altered bronchial mucosa. Major indications for AFI include evaluation of early-stage lung cancer and detection of precancerous lesions. ⋯ This disadvantage could be overcome with the appearance of new and improved technologies in autofluorescence, such as the addition of backscattered light analysis, ultraviolet spectra, fluorescence-reflectance or dual digital systems. Quantitative image analysis is also one of the ways to improve objectivity and minimize observer errors. However, one of the most appropriate solutions would be the addition of AFI to narrow band imaging, and merging the two technologies into one videobronchoscope.
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Expert Rev Med Devices · Jan 2011
ReviewCost-effectiveness of robotic-assisted laparoscopic procedures in urologic surgery in the USA.
New technologies such as robotic-assisted surgery are constantly introduced clinically without a complete understanding of benefits and costs. This article will discuss general concepts of health economics and apply them to the application of robotic-assisted surgery to urologic procedures. Utilization of robotic surgery has increased dramatically in recent years. ⋯ In order for the robot to be cost effective, there needs to be an improvement in efficacy over alternative approaches, and a decrease in costs of the robot or instrumentation. Robotic surgery has not been found to be cost effective in urology. Future studies may yet reveal indirect benefits that are not yet obvious.
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Hemorrhage remains the leading cause of death in combat and the primary cause of preventable death after civilian trauma. Over the last 10 years, major improvements in hemostatic agents have resulted in new dressings that are replacing gauze as the standard of care for compressible hemorrhage. This has inspired a plethora of hemostatic products, some of which have been used in the combat and civilian sector. ⋯ Current research is ongoing to determine which of the available hemostatic agents is the most efficacious. The current recommendation by the Committee on Tactical Combat Casualty Care is that Combat Gauze™ (Z-Medica) is the hemostatic dressing of choice and every soldier carries this dressing in their first aid kit. This article reviews novel hemostatic agents used by first responders in the military and civilian sectors.