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CardioFocus has won a nod from FDA for the next-generation HeartLight X3 Endoscopic Ablation System. The Marlborough, MA-based company said the device is used in the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAFib).
The company received CE mark for the technology in March of 2019. HeartLight X3 is a third-generation technology building upon the advanced features of the HeartLight Endoscopic Ablation System, which performs pulmonary vein isolation (PVI) using laser energy to create lines of scar tissue to block the abnormal electrical pathways that cause AFib.
The approval of the system was based on data from a study of a pivotal confirmatory study. Results from the 60-patient study show the device achieved very rapid PVI in as few as three minutes for a single pulmonary vein.
CardioFocus said all study endpoints were achieved, demonstrating significantly faster ablation and procedures times compared to the previous generation of HeartLight and with comparable safety and efficacy.
Overall procedures times were 73.7 minutes for HeartLight X3 compared to 206 minutes from the historical control study for the original HeartLight. Long-term data from the study found that 71.9% of patients treated with the HeartLight X3 System achieved chronic study success, compared to the historical control HeartLight study of 61.1%.
"FDA approval of the HeartLight X3 System represents a substantial milestone for CardioFocus and is a promising new treatment option for the millions of Americans suffering from paroxysmal AFib," said Burke Barrett, CEO at CardioFocus. "By pairing the most compliant and dynamic balloon technology with the ability to deploy titratable laser energy at unprecedented speed while using direct visualization, we are able to offer a completely unique ablation technology to cardiac electrophysiologists. With this approval in hand, we will initiate a focused rollout of HeartLight X3 across the US."