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Many cardiac implantable device models approved without new clinical data
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Many cardiac implantable electronic device models currently in use have been approved by the FDA’s premarket approval supplement process, which often does not require new clinical data, according to a new report.
Researchers reviewed original and supplement premarket approval (PMA) applications between 1979 and 2012 for cardiac implantable electronic devices, including pacemakers, implantable cardioverter defibrillators and cardiac resynchronization therapy devices, to characterize the changes to the devices made throughout the PMA supplement process.
The PMA pathway is the review process for the highest-risk medical devices, and original PMA applications require clinical data. However, according to the study background, device companies may file PMA supplements to get approval for changes in design, materials, labeling or packaging of their devices, and only one of the five types of PMA supplements requires clinical data.
Fifty supplements per PMA
The researchers found that from 1979 to 2010, the FDA approved 77 original PMA applications and 5,829 supplement PMA applications for cardiac implantable electronic devices, and there were a median of 50 supplements per original PMA (interquartile range, 23-87). Excluding manufacturing changes not altering device design, there were a mean of 2.6 (standard deviation, 0.9) supplements per PMA per year, they found.
PMAs of cardiac implantable electronic devices remained active during a median period of 15 years (interquartile range, 8-20), and 79% of the 77 original PMAs had at least one supplement submitted in 2012.
“The long active life of [cardiac implantable electronic device] PMA approvals suggests that minor design changes may accumulate over time and in some cases may add up to substantial changes from the device approved in the original PMA application,” Benjamin N. Rome, BA, a student at Harvard Medical School, and colleagues wrote.
Two such cases are the Riata (St. Jude Medical) and Sprint Fidelis (Medtronic) ICD leads, which were recalled because of safety issues and approved in supplements that did not require clinical data to PMAs submitted more than a decade earlier, the researchers wrote.
More review may be needed
To guard against a series of minor design changes transforming a device into something very different from what was originally approved, “the FDA could mandate an expert review panel of each PMA every 5 to 7 years in which it is active to evaluate the extent to which clinical data from older models still apply to newer ones,” Rome and colleagues wrote. “Another possibility would be more widespread implementation of rigorous postmarket studies to evaluate device performance once approved for clinical use.”
They noted, however, that the FDA is required to seek the “least burdensome supporting data necessary for review,” that the system enables “useful technological advances [to] be rapidly integrated into clinical care,” and, in some cases, preclinical and animal data are superior to clinical data in assessing changes to cardiac implantable electronic devices.
“In making decisions about use of these high-risk devices, clinicians and patients should consider the strengths and limitations of the PMA supplement approval process,” they wrote.
Disclosure: One researcher is a consultant to the FDA’s Circulatory System Devices Panel.
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