Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads. Hauser RG, Abdelhadi R, McGriff D, Retel LK. They found that nearly all devices used today were approved as PMA supplements to older models. The authors studied cardiac implantable electronic devices approved from 1979-2012, finding that 77 original PMAs were the subject of 5,289 supplement PMAs. FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH. Inclusion of comparative effectiveness data in high-risk cardiovascular device studies at the time of premarket approval. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. Regulation of medical devices in the United States and European Union. Trends in permanent pacemaker implantation in the United States from 1993 to 2009: increasing complexity of patients and procedures. Implantation trends and patient profiles for pacemakers and implantable cardioverter defibrillators in the United States: 1993-2006. Kurtz SM, Ochoa JA, Lau E, Shkolnikov Y, Pavri BB, Frisch D, et al. Papers of particular interest, published recently, have been highlighted as: Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. The FDA must utilize a “least burdensome” approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves.
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