Results announced from study with the HeartLight X3 system

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The HeartLight Excalibur Balloon used with the HeartLight X3 system

CardioFocus recently announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3 system for the treatment of AFib. The results were presented during the Heart Rhythm Society’s 40th Annual Scientific Sessions (8–10 May, San Francisco, USA) and, according to a press release, “demonstrated superior procedural times and impressive procedural outcomes”.

Petr Neužil, head of the Department of Cardiology at Na Homolce Hospital (NHH) in Prague, Czech Republic, and the trial’s lead investigator, outlined the findings during a presentation titled, “Performance of a 3rd generation visually-guided laser balloon for pulmonary vein isolation: Results of the X3 study.” In the evaluation of 60 patients, the HeartLight X3 system consistently achieved very rapid pulmonary vein isolation (PVI), in as few as three minutes for a single vein.

The HeartLight X3 system is a third generation AFib ablation technology, building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs PVI using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib. Using direct tissue visualisation, titratable laser energy, and compliant balloon technology, the HeartLight X3 system’s unique RAPID mode leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician resulting in consistently reduced procedure times.

“Our trial results using the HeartLight X3 system were outstanding, with the study meeting all the pre-specified endpoints,” said Petr Neužil. “With faster PVI and faster total ablation times combined with the already established safety and efficacy of the current HeartLight System, I anticipate that the HeartLight X3 system will be quickly adopted in the clinical setting.”

The key findings of the study included:

  • HeartLight X3 procedure times were more than 90 minutes shorter than with the first generation HeartLight System; procedures can routinely be completed in one hour
  • HeartLight X3 was able to isolate pulmonary veins in as fast as three minutes
  • HeartLight X3 demonstrated comparable acute safety and efficacy to the first generation HeartLight system
  • Ninety-nine percent of pulmonary veins were isolated acutely with the HeartLight X3 system
  • Fluoroscopy times with HeartLight X3 were under seven minutes per procedure, substantially lower than with the first generation HeartLight system

“CardioFocus is experiencing tremendous growth; more than 6,500 patients have been treated with our revolutionary HeartLight system and the HeartLight X3 system is poised to make a real impact on the AFib ablation space with its recent CE Mark approval,” said Burke T Barrett, president and chief operating officer at CardioFocus. “We believe coupling the HeartLight system’s unique feature set and its safety and effectiveness profile with the straightforward introduction of X3 Rapid mode for accelerating procedures, will result in an unparalleled PVI ablation tool.”

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

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