Many cardiovascular devices gain FDA approval without clinical data

Many cardiovascular medical devices are approved via a process that does not require new clinical data, according to a study published this week in the Journal of the American Medical Association.

For the study, Benjamin Rome of Harvard Medical School and Brigham and Women's Hospital, and colleagues used the U.S. Food and Drug Administration's premarket approval database to review cardiovascular devices approved as PMA supplements from 1979 through 2012, identifying the number and change of supplements to each original PMA .

The researchers found that 37 percent of supplements represented at least minor alterations to the device's design or materials. Among 180-day supplements approved between 2010 and 2012, only 23 percent included new clinical data to support safety and effectiveness.

"[O]ur results should not be interpreted to indicate that the FDA is failing to review PMA supplement applications to determine safety and effectiveness," the authors said, according to an announcement. "However, clinicians and patients should be aware that clinical data are rarely collected as part of PMA supplement applications prior to marketing."

In the U.S., the Food and Drug Administration reviews high-risk medical devices via the pre-market approval (PMA) system. This allows some devices to pass without actually being tested in humans, such as the Medtronic Sprint Fidelis and the St. Jude Medical Riata implantable cardioveter-defibrillators (ICDs), according to JAMA.

According to the FDA, the process of approval by premarket approval supplement "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."

Last fall, former vice president Dick Cheney told CNN's Sanjay Gupta that when he was in office, his doctors turned off the wireless function of his implanted cardiac defibrillator (ICD) "in case a terrorist tried to send his heart a fatal shock."

Meanwhile, in September 2012, the Government Accountability office released a report stating that the Food and Drug Administration needs to pay more attention to the information security risks for implantable medical devices--such as heart defibrillators and insulin pumps--including the threat of hacking and sabotage.

To learn more:
- here's the study's abstract
- read the JAMA announcement


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