Expert review of medical devices
-
The number of current advances in robotic surgery for the pediatric population is growing every day: the different procedures range from extirpative to reconstructive, including pyeloplasty, reimplantation, catheterizable channels and augmentation. Despite its early success, robotic surgery still poses many challenges in pediatric patients. ⋯ There are many other procedures that can be performed with the robot, such as ureteral reimplantation, and nephrectomy, both total and partial. The reconstructive aspect has been taken to the next level where more difficult procedures, such as appendicovesicostomy and bladder augmentation, can be performed in children.
-
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.
-
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.