CardioFocus gets CE-Mark for HeartLight X3 device

27 March 2019 (Last Updated March 27th, 2019 14:13)

CardioFocus has secured a CE mark for the latest version of its endoscopic ablation system HeartLight.

CardioFocus gets CE-Mark for HeartLight X3 device
The HeartLight Excalibur Balloon used with the new HeartLight X3 System. Credit: PRNewsfoto/ CardioFocus, Inc.

CardioFocus has secured a CE mark for the latest version of its endoscopic ablation system HeartLight.

Called HeartLight X3, this pulmonary vein isolation (PVI) device uses laser energy to generate scar tissue to block the abnormal electrical pathways that are responsible for atrial fibrillation.

The latest HeartLight X3 version features direct tissue visualisation, titratable laser energy and balloon technology, as well as has a RAPID mode that decreases procedure times by using precise motor control.

CardioFocus president and chief operating officer Burke Barrett said: “We are eager to begin the commercialisation of the breakthrough HeartLight X3 system in the European market.

“We feel confident that the HeartLight X3 system is poised to change the way AFib ablation is performed in Europe.”

“In partnership with our physician users, we are committed to continued innovation and delivering the best treatment modalities in the AFib ablation space.”

According to data from a pivotal confirmatory trial conducted in 60 patients, HeartLight X3 demonstrated consistent rapid PVI for a single vein within three minutes, completing the procedure in 20 minutes.

Trial investigator Boris Schmidt said: “Our clinical results using the HeartLight X3 system have been outstanding, with unprecedented treatment speed and precise lesion creation.

“Based on our experience with the device, we feel confident that the HeartLight X3 system is poised to change the way AFib ablation is performed in Europe.”

The HeartLight system has been used to treat more than 6,000 atrial fibrillation patients across the US, Europe and Japan.

Atrial fibrillation is a common cardiac rhythm disorder that affects more than 33 million people globally. In Europe, the number of patients is predicted to reach up to 17 million by 2030.