Heartlight X3 gains European CE Mark



The HeartLight Excalibur Balloon used with the HeartLight X3 system
The HeartLight Excalibur Balloon used with the HeartLight X3 system

CardioFocus has announced the European CE Mark approval for its HeartLight X3 endoscopic ablation system, used in the treatment of atrial fibrillation.

The HeartLight X3 system is a third-generation technology that performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause atrial fibrillation. According to a press release from CardioFocus, using direct tissue visualisation, titratable laser energy, and compliant balloon technology, the HeartLight X3 system has a unique RAPID mode that leverages a precise motor control system to enable uninterrupted, high-speed, circumferential lesion creation under direct control of physicians, which results in consistently reduced procedure times.

In the press release, Boris Schmidt (Cardioangiologisches Centrum Bethanien, Frankfurt, Germany), an investigator in the confirmatory trial of the system, says: “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 atrial fibrillation ablation is performed in Europe.”

The press release adds that the trial evaluated 60 patients, and that the HeartLight X3 system consistently achieved very rapid pulmonary vein isolation in as few as three minutes for a single vein. The trial also found that the system has the potential to complete all required ablations in less than 20 minutes.

The company states that commercial introduction of the HeartLight X3 system in Europe will begin immediately, and that current users of the HeartLight platform may start using HeartLight X3 technology after a simple upgrade.

Burke T. Barrett, president and chief operating officer at CardioFocus, says: “We are eager to begin the commercialisation of the breakthrough HeartLight X3 system in the European market. In partnership with our physician users, we are committed to continued innovation and delivering the best treatment modalities in the atrial fibrillation ablation space.”

The HeartLight X3 system is only approved for use in Europe, and is not available for sale in the USA.


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