CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system

HeartLight Excalibur Balloon HeartLight X3 system CardioFocus AFib catheters AF — The HeartLight Excalibur Balloon used with the HeartLight X3 system. [Image courtesy of CardioFocus]

CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S.

The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in the U.S. immediately after receiving the PMA supplement, the company announced yesterday.

This supplement follows the original, approved PMA of the company’s HeartLight endoscopic system.

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