The development and introduction of new medical devices have radically changed the practice of medicine. No area of medicine has been affected more than cardiology, with new devices facilitating the effective treatment of coronary artery disease (percutaneous coronary interventions [PCIs]/ stents), valvular heart disease (mechanical and bioprosthetic valves), and electrophysiological disorders ...

Recent correspondence in the British Medical Journall-4 has discussed the need for oxygen-failure devices and the philosophy of their design, so we shall not repeat this discussion here. Briefly, however, we think that very occasional oxygen failures are inevitable, during both anaesthesia and artificial ventilation with oxygen. Because the danger is so remote any safety device that is to gain ...

OBJECTIVES To assess the safety and acceptance of the PrePex device for medical male circumcision (MMC) in rural Uganda. METHODS In an observational study, HIV-uninfected, uncircumcised men aged 18 and older who requested elective MMC were informed about the PrePex and dorsal slit methods and offered a free choice of their preferred procedure. 100 men received PrePex to assess preliminary saf...

BACKGROUND A novel soft tissue filler composed of polymethylmethacrylate (PMMA) microspheres suspended in a collagen gel matrix containing 0.3% lidocaine (ArteFill, Artes Medical, Inc.) was recently approved by the Food and Drug Administration for the correction of nasolabial folds. A randomized, multicenter, controlled pivotal trial performed in the United States established the safety and eff...

Establishing a national health policy at a macro level involves the integration of a series of health initiatives across a spectrum of activities, including clinical care. Evaluation of the safety and efficacy of a new medical device ultimately evolves to testing in humans. The pathway to a formal prospective clinical trial includes a stepwise appreciation of pre-clinical data and detailed anal...

The interaction between a medical device and a pharmaceutical solution it contacts may dictate solution safety and/or efficacy. Of specific concern is the ability of device components to leach into the contacting solution. As pharmaceutical solutions containing surfactants, co-solvents and solubilizing agents become more common, method's for assessing the extent of leaching are needed. In this ...

Corticosteroids are the mainstay of treatment for refractory chronic rhinosinusitis. The off-label use of steroid-eluting stents has increasingly gained popularity in functional endoscopic sinus surgery for decreasing postoperative inflammation and synechiae formation. However, there is a paucity of data outlining the safety profile of this device despite its widespread use. This study was desi...