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.
The HeartLight X3 system uses laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. It offers a Rapid mode that leverages a precise motor control system for uninterrupted, high-speed, circumferential lesion creation. The result, according to CardioFocus, is reduced procedure times.
“The excitement surrounding the introduction of HeartLight X3 into the European market has been palpable,” CardioFocus CEO Burke T. Barrett said in a news release.
“We have treated nearly 500 patients with the technology and the ability to deploy rapid, continuous laser energy circumferentially and outside of the pulmonary vein is compelling,” Barrett said. “The submission of this PMA supplement marks a tremendous milestone as we prepare to bring this breakthrough product to the U.S.”