June 16, 2020
CardioFocus Begins Introduction of HeartLight X3 System for the Treatment of AFib
June 16, 2020—CardioFocus, Inc. announced that the first United States patients have been treated commercially with the recently approved HeartLight X3 endoscopic ablation system. The cardiac ablation technology is designed to treat drug-refractory, symptomatic paroxysmal atrial fibrillation (PAF).
In May, the HeartLight X3 system received FDA approval for the treatment of drug-refractory recurrent symptomatic PAF. Approval was supported by data from a study of the HeartLight X3 in the treatment of 60 patients over 12 months. All study endpoints were achieved, and the device achieved very rapid pulmonary vein isolation in as few as 3 minutes for a single pulmonary vein.
Henry D. Huang, MD, of Rush University Medical Center in Chicago, Illinois, and David Kenigsberg, MD, of Westside Regional Medical Center in Plantation, Florida performed the first procedures using the X3 system.
“We are dedicated to providing our patients the most efficacious and innovative treatment options for AFib, a common but treatable heart condition,” commented Dr. Huang in the company's announcement. “As the initial medical center in the United States to offer the HeartLight X3 system, we look forward to being able to provide effective symptom relief for Chicago-area patients safely, confidently, and quicker than ever before. We are excited by the results we've seen thus far, which build upon the positive outcomes we experienced in treating more than 100 patients with previous versions of HeartLight.”
Dr. Kenigsberg added, “Early on, I recognized the potential of the HeartLight system and after using it to treat more than 40 patients, I have been eager to offer the next generation, HeartLight X3, to our patients here in South Florida. I believe the technology has true game-changing potential in how it facilitates pulmonary vein isolation.”