Medical devices and the FDA approval process: balancing safety and innovation; comment on "prevalence of fracture and fragment embolization of bard retrievable vena cava filters and clinical implications including cardiac perforation and tamponade".
Redberg
Rita F
RF
Department of Medicine, University of California, San Francisco, 505 Parnassus, M-1180, San Francisco, CA 94143-0124, USA. redberg@medicine.ucsf.edu
D002305:Cardiac Tamponade / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004617:Embolism / Q000453:epidemiology* / Q000209:etiology; D006335:Heart Injuries / Q000453:epidemiology* / Q000209:etiology / Q000517:prevention & control; D006801:Humans; D015995:Prevalence; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011655:Pulmonary Embolism / Q000517:prevention & control*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D016306:Vena Cava Filters