HeartLight 10K & Beyond

CardioFocus was founded as a med/tech company and started focusing on atrial fibrillation (AF) ablation just after the genesis of modern AF ablation techniques. CardioFocus chose the 980nm laser because it creates an optimal lesion volume in the atrial tissue by balancing absorption with penetration. Both an epicardial and an endocardial ablation system were developed.

The first iteration of the HeartLight catheter included 20, 25, and 30mm non-compliant balloons. These utilized a full 360 degree ring of ablation for energy delivery. With further input from the scientific advisory board, the endoscope was added to the catheter in the second iteration for direct visualization of tissue contact and ablation.

Pre-clinical studies compared the use of HeartLight to the gold standard radiofrequency ablation (RFA) in an in-vivo porcine model. Transmural lesions were seen in 100% of variable-dose laser sections. This demonstrated that transmural and circumferential lesions can be created with 980nm laser ablation.

The HeartLight Endoscopic Ablation System received European CE Mark approval, introducing an advanced feature set to physicians for pulmonary vein isolation (PVI) for patients with paroxysmal atrial fibrillation (AF). Physicians were now able to directly visualize pulmonary veins while having the ability to titrate their dosing with a compliant balloon, allowing for a safe and efficacious AF ablation procedure.

A randomized, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centers across the United States evaluating CardioFocus’ HeartLight Endoscopic Ablation System versus the Biosense Webster Thermocool catheter. Results showed HeartLight met both primary efficacy and safety endpoints and demonstrated a short learning curve for physicians.

Based on the results of the pivotal clinical study, the HeartLight Endoscopic Ablation System received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with recurrent, drug refractory paroxysmal atrial fibrillation (PAF). The HeartLight System’s unique feature set provides physicians with the ability to directly visualize patient veins using a compliant balloon and titratable laser energy.

The HeartLight Endoscopic Ablation System received PMDA approval for the treatment of paroxysmal atrial fibrillation (AF) in Japan from the Japanese Ministry of Health, Labour and Welfare. To support Japanese approval, CardioFocus established a distribution partnership with Japan Lifeline Co., Ltd. (JLL).

The HeartLight Excalibur Balloon™, a next-generation technology designed for the treatment of atrial fibrillation (AF), received European CE Mark approval. The Excalibur Balloon introduced an ultra-compliant balloon with an advanced feature set that optimizes speed and magnitude of tissue contact during pulmonary vein isolation (PVI) procedures.

The HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of atrial fibrillation (AF), received approval from the U.S. Food and Drug Administration (FDA). The ultra-compliant Excalibur Balloon expands to fit a wide range of patient anatomies and introduces Dynamic Response Technology™ to empower the physician to achieve antral contact. This leverages the same proven titratable laser energy source of the HeartLight platform.

The HeartLight X3 Endoscopic Ablation System™, a third-generation technology building upon the advanced features of the HeartLight Endoscopic Ablation System, received European CE Mark approval. 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.

The HeartLight Endoscopic Ablation System reached over 100 active centers globally, spanning the U.S., Europe and Japan.

The U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight X3 Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). The approval of the HeartLight X3 System came as a result of a comprehensive submission which included outcomes from the study of 60 HeartLight X3 patients. In this pivotal confirmatory study, the X3 System achieved very rapid pulmonary vein isolation (PVI), in as few as three minutes for a single pulmonary vein.