Some Cardiac Devices Approved Without Updated Clinical Data


January 23, 2014
FDA Premarket Approval PMA Clinical Study EP Lab Cath Leads Implantable Devices
St. Jude Medical Riata
January 23, — The U.S. Food and Drug Administration (FDA) has approved many cardiac implantable electronic device models currently in use through a review process in which models were deemed safe and effective based on approval of prior versions of the device, according to a study published in JAMA.
The premarket approval (PMA) process used by the FDA has attracted attention in recent years after recall of device components that were not tested clinically in human trials prior to approval because they were design changes to prior-marketed devices, and considered supplements to previously submitted PMA applications. Examples cited in the report include leads from Medtronic Sprint Fidelis and St. Jude Medical Riata implantable cardioverter-defibrillators (ICDs).
PMA supplemental approval "allow[s] patients to benefit from incremental innovation in device technology by providing efficient and inexpensive FDA review pathways for smaller device changes. Supplements may include major or minor design changes as well as routine changes in labeling, materials or packaging. By statute, the FDA must seek only the 'least burdensome' supporting data necessary for review."
Benjamin N. Rome, B.A., of Harvard Medical School and Brigham and Women's Hospital, Boston, and colleagues used the FDA's PMA database to review CIEDs (including pacemakers, ICDs, and cardiac resynchronization therapy [CRT] devices) approved as PMA supplements from 1979 through 2012. They identified the number of supplements to each original PMA and characterized the nature of the changes in each supplement.
77 approved PMA applications for CIEDs (46 pacemaker devices, 19 ICDs, and 12 CRT devices) were the basis for 5,829 PMA supplement applications, with a median of 50 supplements per original PMA. In the last decade, the number of approved supplements annually increased to 704. Excluding manufacturing changes that do not alter device design, the number of supplements approved each year averaged 2.6 per PMA per year.
37 percent of supplements represented at least minor alterations to the device's design or materials. Among 180-day supplements (a type of FDA review process) approved between 2010 and 2012, 23 percent included new clinical data to support safety and effectiveness.
"Our results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness," the authors reported. “However, clinicians and patients should … be aware … that clinical data are rarely collected as part of PMA supplement applications prior to marketing.”
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