The HeartLight Endoscopic Ablation System is now offered at more than 100 hospitals worldwide. CardioFocus highlighted the expanded availability of its catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI) in a press release.
According to the press release, more than 6,500 patients have been successfully treated in the USA, Europe and Japan with the HeartLight System. The system is a treatment option for patients whose heart arrhythmias are insufficiently controlled with medication.
Tristram D Bahnson, an electrophysiologist at Duke University Health System and founding director of the Duke Center for Atrial Fibrillation, commented in the release: “We have treated dozens of patients with the system, which allows direct visualisation of ablation targets during the procedure, and we are encouraged by the outcomes so far. For practising clinical electrophysiologists, it’s important to reduce the need for repeat ablation procedures by using ablation systems that facilitate precise and durable lesion delivery, which is facilitated by the HeartLight system.”
Duke was one of 19 participating sites in the clinical evaluation of the HeartLight System. The trial—Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System—was a randomised, controlled trial with 353 participants across the USA. The results led to the device’s US Food and Drug Administration (FDA) approval in 2016. In 2018, the next-generation Excalibur Balloon received FDA approval for use as part of the HeartLight System, and in March 2019, the HeartLight X3 System received European CE Mark approval.
Omari V Bouknight, president and chief commercial officer at CardioFocus said: “We have seen a surge in demand for the HeartLight System and have more than doubled the number of hospitals offering the technology over the last 12 months.”