Regulatory Focus™ > News Articles > 2019 > 1 > FDA Launches Probe into Drug-containing Balloons, Stents

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Posted 18 January 2019 | By Ana Mulero 

FDA Launches Probe into Drug-containing Balloons, Stents

Paclitaxel-coated balloons and paclitaxel-eluting stents prompted a US Food and Drug Administration (FDA) letter to health care providers after a 2018 meta-analysis suggested an increased mortality rate in patients that received peripheral arterial disease (PAD) treatment with either of the device types.

All-cause patient mortality rate at two years “significantly increased” and “increased further” after up to five years, following use of paclitaxel-coated balloons or paclitaxel-eluting stents versus the bare device alternatives, the meta-analysis found. “Further investigations are urgently warranted,” the researchers wrote in the article published in the Journal of the American Heart Association last December.

FDA’s Thursday letter to health care providers comes in response to the new information that the study presented. The agency told health care providers that it is “currently evaluating available long-term follow-up data to determine if there are any long-term risks associated with paclitaxel-coated products.”

“We’re reviewing all available information quickly and thoroughly and will communicate as soon as we know more,” FDA Commissioner Scott Gottlieb added. “The identification of this risk, and our work to notify patients and providers, reinforces why post-market surveillance of medical devices is pivotal and why our ongoing investment in these capabilities is a key part of our work to protect patients.”

The agency’s review will be focused on causes of death, paclitaxel doses delivered and patient characteristics. It also involves working with manufactures of the drug-containing balloons and stents.

Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality - Letter to Health Care Providers


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