Feb. 13, 2013

Public Citizen: FDA Should Require Intra-Aortic Balloon Pumps to Be Tested in People for Safety and Effectiveness

Life-Supporting Medical Device Carries Significant Risks, Should Undergo  Clinical Testing Before Being Sold

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) should require intra-aortic balloon pump (IABP) devices to undergo human testing before being approved for use in all conditions, Public Citizen said in a letter today to the agency.

However, the agency is recommending that the device be cleared for its most common uses, including heart attacks, without such tests.

The FDA’s proposal is particularly concerning in light of the known risks of the device. Since 2002, 189 deaths and 1,797 injuries associated with the pump have been reported to the FDA. A total of 3,449 malfunctions of IABP devices also have been reported during that time, with the number of such reports rising sharply over the past five years.

IABP devices provide mechanical assistance to the heart in cases where the heart cannot maintain sufficient blood flow to the rest of the body. They are among a number of devices that were on the market prior to the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA), which granted the FDA the authority to review and regulate medical devices before approval. Such devices are therefore known as “preamendment” devices.

For approval purposes, the FDA classifies all medical devices into three regulatory categories, Class I, II or III. Only Class III devices are typically required to undergo clinical testing in human patients to demonstrate safety and efficacy, while Class I and II devices are exempt from this mandate.

Some preamendment devices, including IABP devices, were considered by FDA’s expert advisory panel in 1976 to be life supporting and risky enough to require Class III approval. However, due to a backlog dating back to the original 1976 amendment, the FDA never finalized the process for requiring premarket approval and clinical trials for these devices. The result is that the devices have effectively been treated as Class II devices and have consequently been sold for years without a requirement that they be tested on people to ensure they are safe and effective.

Rather than finalize the process of requiring premarket approval, the FDA is now proposing to forgo the clinical testing process by offering Class II designation for three of the most common uses of the device: acute coronary syndrome (which includes heart attacks) when accompanied by heart dysfunction, congestive heart failure, and before, during or after any surgical procedure. Less common uses will remain in Class III and require premarket approval with clinical testing.

In 2012, the largest randomized clinical trial of the device to date showed that IABP therapy was ineffective for use in heart attack patients with low blood pressure, refuting decades of historical experience on which the FDA is largely basing its recommendation.

“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 Dr. Sammy Almashat, a researcher with Public Citizen’s Health Research Group. “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 is urging the FDA to maintain IABP devices as Class III medical devices and to require premarket approval for all indications.

Read the letter here.