Expert review of medical devices
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Expert Rev Med Devices · Jan 2008
ReviewRole of pre- and intraoperative imaging and neuronavigation in neurosurgery.
Advances in neuroimaging acquisition, computing and image processing have enabled neurosurgeons to use radiological imaging to guide both preoperative planning and intraoperative guidance. In preoperative planning, imaging may be used to evaluate surgical risks, choose the best method of intervention and select the safest surgical approach. ⋯ In the following review, we briefly examine the history of neuroradiology for neurosurgery, neuronavigation and intraoperative imaging and trace their advances to current systems in use. We will also highlight new experimental applications of neuroimaging that are currently being refined.
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Expert Rev Med Devices · Jan 2008
US FDA perspective on the regulations of medical-grade polymers: cyanoacrylate polymer medical device tissue adhesives.
This article provides a brief description of the uses and clinical applications of medical-grade polymers, in particular synthetic cyanoacrylate adhesive/glue devices that have been cleared and/or approved as medical devices by the US FDA since the Medical Device Amendments of 1976 were enacted. This includes Class I cyanoacrylate devices (e.g., liquid bandages), Class II cyanoacrylate devices (e.g., dental cements), and Class III (premarket approval) cyanoacrylate devices such as Dermabond, Indermil Tissue Adhesive, Histoacryl and Histoacryl Blue Topical Skin Adhesive, and Trufill n-Butyl Cyanoacrylate Embolic Agent. ⋯ It includes the FDA issues regarding the published guidance document for 'Cyanoacrylate Topical Tissue Adhesives' that will provide guidance to regulatory personnel and manufacturers in the preparation of investigational device exception applications and in the development of valid scientific evidence to support premarket approval applications for cyanocrylate tissue adhesives intended for topical approximation of skin and others. The article provides a short regulatory description of the US FDA; under what laws its operates, how the FDA evaluates new devices for marketing, and how the device regulatory system works, for example, Class I, Class II, and Class III cyanoacrylate medical devices.
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Expert Rev Med Devices · May 2007
ReviewClinical experience with the iLA Membrane Ventilator pumpless extracorporeal lung-assist device.
Extracorporeal gas exchange by extracorporeal membrane oxygenation has been established clinically in patients with acute lung failure. The interventional lung-assist (iLA) Membrane Ventilator device (Novalung) is a sophisticated representative of a new generation of pumpless extracorporeal lung-assist devices that are driven by the patient's cardiac output and therefore, do not require extracorporeal pump assistance. ⋯ This particular pumpless extracorporeal lung-assist device was applied in 1800 patients for artificial lung assistance with easy use and low cost. This article reviews the present state of clinical Novalung device implementation focusing on encountered limitations and conceivable future developments in the field.
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Expert Rev Med Devices · May 2007
ReviewNegative pressure ventilation via diaphragmatic pacing: a potential gateway for treating systemic dysfunctions.
Programmed diaphragmatic pacing using implanted neuromodulators represents an emerging method for providing pulmonary support using negative pressure ventilation. The implantable, rechargeable, programmable and miniaturized nature of diaphragmatic pacers may obviate many of the management issues associated with noninvasive positive pressure ventilation devices. ⋯ In addition, it might alleviate subclinical hypoventilation--a condition that may affect a significant proportion of the aging population. Diaphragmatic pacing could also reduce sympathetic bias, which may contribute to a wide range of diseases associated with autonomic dysfunction.