FDA official delivers government agency’s early reaction to latest contentious meta-analysis on paclitaxel-coated devices


HOLLYWOOD, Fla.—A Food and Drug Administration (FDA) official delivered a talk which represents the government agency’s earliest public reaction to the latest meta-analysis suggesting significantly reduced amputation-free survival at one year when paclitaxel-coated balloons are applied in arteries below the knee for critical limb-threatening ischemia (CLTI) treatment.

Speaking at the 2020 International Symposium on Endovascular Therapy (ISET) held in Hollywood, Florida, Jan. 17–20, Ryan Randall, of the FDA’s peripheral interventional devices team, said given that it had been only a week since the study from Konstantinos Katsanos, MD, and colleagues had been released, they had not yet fully discussed and analyzed the publication internally but continued to work to understand the paclitaxel signal.

“We do note, though, that none of the devices included in this study are available in the U.S.,” he said. “There are currently no stents or drug-coated balloons approved for use below the knee in the U.S.”

Randall summed the FDA position thus: “Our current thinking regarding approved devices is that paclitaxel devices may remain on the market given that benefits may outweigh the risks for some patients based on clinical judgement.”

He said the FDA recommends doctors continue to discuss all treatment options with patients.

“Regarding ongoing and future trials, we have worked to update informed consent forms to ensure patients are informed of the risk,” Randall said. “We’ve worked to closely monitor enrolled patients and worked to improve the collection of data and minimize missing data for these trials.”


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