Titlebook: Clinical Evaluation of Medical Devices; Principles and Case Karen Becker Witkin Book 1998 Springer Science+Business Media New York 1998 bi

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Choosing and Evaluating Outcome Measures for Clinical Studies of Medical Devicesrs with guidelines for producing Premarket Approval Applications (PMAs) that contain scientific evidence for device safety and effectiveness.. Traditionally, clinical trials are recommended by the FDA for evaluation of the safety and effectiveness of diagnostic and/or therapeutic interventions. Clin

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Prospective Multicenter Clinical Trials in Orthopedicsorthopedics date back over 30 yr and the 1976 Medical Device Amendments of the Food, Drug, and Cosmetic Act are commemorating 20 yr, it has been scarcely more than a decade that orthopedic clinical studies have been conducted with any degree of consistency. Pharmaceutical clinical research has a mor

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Long-Term Evaluation of Total Hip Arthroplastyplant can almost always be guaranteed substantial pain relief, greatly improved range of motion, and an improved quality of life. Unfortunately, many patients will, over time, experience a subsequent loosening of their prosthesis and a return of the clinical symptoms that led to the original arthrop

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Injectable Collagen and a Rare Adverse Event—True Association or Artifact? long history of safe and effective use.. Zyderm® and Zyplast® implants are forms of injectable bovine collagen (highly purified bovine dermal collagen, containing at least 95% Type I and < 5% Type III collagen in a fibrillar suspension of physiologic buffered saline and 0.3% lidocaine). Injectable

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A Controlled Study of Intra-Articular Hyalgan® in the Treatment of Osteoarthritis of the Kneeified hyaluronic acid (500–730 kDa), prepared as a buffered solution in physiologic saline. Hyalgan is injected intra-articularly for the sustained relief of pain and joint dysfunction in osteoarthritis of the knee. This product is classified as a device according to the current ruling of the US Foo

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Role of Device Retrieval and Analysis in the Evaluation of Substitute Heart Valvesisease, and improves the survival and enhances the quality of life of many individuals.. Nevertheless, problems associated with prostheses remain a major impediment to the long-term success of this procedure. Despite considerable improvement in the technology of heart valve replacement devices since

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Polyurethane Pacemaker Leadsay not be able to detect low-level or long-term complications. No matter how much premarket work one does and no matter how sophisticated the protocols, the only valid proof of long-term reliability is performance in the field; that is, through postmarket surveillance. Even studies on the long-term