The prominent consumer watchdog group Public Citizen is calling on federal regulators to require that all intra-aortic balloon pumps (IABP) be put through rigorous clinical trials before being placed on the market, to ensure that they are safe and effective.
In a letter to the FDA (PDF), Public Citizen warned the agency that its current policy of allowing the use of the balloons, which are used in the prevention of heart attacks, without human testing is dangerous.
The letter comes following a clinical trial in 2012, which showed that intra-aortic balloon pump therapy did not help heart attack patients with low blood pressure.
The group says that the FDA passed up an opportunity to require the devices to undergo premarket approval when they are designed for the use of acute coronary syndrome, congestive heart failure and surgical procedures. Less common uses require premarket approval clinical testing.
Intra-aortic balloon pump (IABP) devices help the heart maintain bloodflow to the rest of the body. Currently they are treated as Class II medical devices, which can be approved through the use of the FDA’s controversial 510K fast-track approval process. That means that all manufacturers have to show is that they are substantially equivalent to devices currently on the market. Public Citizen is calling for them classified as Class III devices; a category for the most critical medical devices.
“Life-supporting and risky medical devices, such as IABP devices, always should be tested prior to approval to ensure that they are safe and effective for all of the marketed indications,” said Public Citizen researcher Dr. Sammy Almashat in a press release. “By permanently removing this requirement for the most common uses of these devices, the FDA is dangerously relying on largely unsubstantiated ‘expert consensus’ of the sort that has recently been overturned by rigorous clinical trials.”
Public Citizen indicates that intra-aortic balloon pump problems have contributed to at least 189 deaths and 1,797 injuries since 2002.