Medical device firm CardioFocus has secured CE mark approval for its HeartLight X3 endoscopic ablation system to treat atrial fibrillation (AFib).
Image: HeartLight Excalibur Balloon used with the new HeartLight X3 system. Photo: courtesy of PRNewswire / CardioFocus, Inc.
HeartLight X3 system is a third generation technology developed by using advanced features from the HeartLight endoscopic ablation system.
HeartLight endoscopic ablation system carries out pulmonary vein isolation (PVI) using laser energy to form lines of scar tissue to restrict the abnormal electrical pathways that cause AFib.
Through using direct tissue visualization, titratable laser energy and compliant balloon technology, HeartLight X3 system’s advanced RAPID mode is said to leverage a precise motor control system that facilitates circumferential lesion creation under direct control of the physician.
The system steadily achieved very rapid PVI within three minutes for a single vein in the pivotal confirmatory assessment of 60 patients.
The study also demonstrated that the system holds capacity to complete all required ablations within 20 minutes.
The pivotal confirmatory trial investigator Dr Boris Schmidt said: “Our clinical results using the HeartLight X3 System have been outstanding, with unprecedented treatment speed and precise lesion creation.”
CardioFocus said it will immediately initiate the commercial introduction of the HeartLight X3 system in Europe and current users of the HeartLight platform can use HeartLight X3 technology after a simple upgrade.
HeartLight X3 system is not yet approved for commercial sale in the US.
CardioFocus president and chief operating officer Burke Barrett said: “We are eager to begin the commercialization 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 AFib ablation space.”
HeartLight endoscopic ablation system was already used to treat over 6,000 patients in the US, Europe and Japan, said CardioFocus.
In September 2017, CardioFocus also secured CE mark approval for its next-generation HeartLight Excalibur Balloon to treat AFib.
The next-generation technology helps to advance the speed and magnitude of target tissue contact during PVI procedures.