CardioFocus, Inc., a medical device company focused on advancing ablation treatments for atrial fibrillation (Afib), has made notable strides in the development of its next-generation Pulsed Field Ablation (PFA) technology. This innovative approach utilizes an electric field with a high voltage current between electrodes to ablate cardiac tissue, potentially reducing safety concerns such as esophageal heating during cardiac ablation for Afib.
The company is building on the clinical performance of its HeartLight X3 System to overcome the limitations of current PFA catheters used for pulmonary vein isolation (PVI). The HeartLight System's highly compliant balloon and direct visualization capabilities ensure optimal catheter/tissue contact, addressing the challenges posed by the variability in human pulmonary vein anatomy. With patents for HeartLight PFA technology filed earlier this year, CardioFocus anticipates the first human use of this technology in early 2023.
To further its groundbreaking developments in PFA, CardioFocus has established a Clinical Advisory Board (CAB) comprising leading experts in the field. The CAB has collaborated with CardioFocus on the system's development, expressing optimism about the initial pre-clinical results and the potential of the HeartLight System to deliver precise lesions around pulmonary veins using direct visualization.
Atrial fibrillation affects millions globally, and CardioFocus is committed to improving long-term outcomes for patients undergoing PVI procedures. The HeartLight X3 System, with its unique combination of a highly compliant balloon and direct visualization, offers a promising solution for precise energy delivery, potentially reducing safety concerns associated with high power delivery. Recent data presented at HRS 2022 highlighted the HeartLight X3 System's high lesion durability and one-year freedom from atrial fibrillation, underscoring its effectiveness in treating Afib.
The HeartLight X3 System represents a revolutionary approach to catheter ablation technology for PVI, the gold standard treatment for Afib. By integrating direct tissue visualization, titratable laser energy, and compliant balloon technology, the HeartLight X3 System provides a differentiated PVI solution for patients whose Afib is not adequately controlled with medication. With its RAPID mode, the system enables uninterrupted, high-speed, circumferential lesion creation under direct physician control, offering reduced procedure times and excellent predictability.
CardioFocus, headquartered in Marlborough, MA, continues to innovate in the field of cardiac ablation treatments, aiming to enhance the quality of life for patients suffering from atrial fibrillation and other cardiac disorders.
