Update on an article published in the Q3 2019 edition of The Source.

Head Shot of Robin Cunningham
Robin Cunningham, MSN, RN

In January 2019, the Food and Drug Administration (FDA) sent out a warning letter to physicians and healthcare providers regarding a late-mortality safety signal with paclitaxel-coated balloons and stents, says Robin Cunningham, MSN, RN, former Director of Clinical Research at HealthTrust. In August, they released their official recommendations regarding the use of these products.

“The panel unanimously agreed that the short-term benefits of paclitaxel-coated devices for peripheral arterial disease continue to outweigh the risks,” Cunningham says. “Patients who have received these devices had good outcomes for the most part, and for that reason, devices will remain available on the market.”

The FDA determined that physicians who implant a paclitaxel-coated device must diligently monitor patients, and they must properly inform patients regarding the increased rate of long-term mortality (as well as alternative treatment options) before implanting the devices.

In addition, Cunningham says the FDA will change the labeling on these devices to reflect the five-year mortality signal. The FDA will also be working with manufacturers to modify their informed consent to include information about this mortality signal.

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