J&J used RWE for an expanded indication — and you can, too

Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions.

J&J MedTech’s Biosense Webster ThermoCool SmartTouch [Image courtesy of J&J MedTech]

Real-world evidence (RWE) took a big step forward recently when the FDA approved an expanded indication for a Johnson & Johnson MedTech ablation catheter.

For the first time, the federal medical device safety regulator approved a label expansion based on RWE from a retrospective study of health records documenting off-label use by physicians.

“The clinical evidence used to support the expansion of indications was based solely on an analysis of a dataset comprised of electronic health records from two hospital systems,” the agency said. “The FDA worked closely with the study sponsor to ensure that the RWE resulting from the analysis was both relevant and reliable…

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