The FARAPULSE PFA System delivers pulsed field energy and consists of the FARAWAVE™ Ablation Catheter, the FARASTAR™ Ablation Generator, and the FARADRIVE™ Steerable Sheath, which is complemented by the VersaCross Connect™ Access Solution for the FARADRIVE Steerable Sheath to provide safe and efficient access to the left side of the heart during procedures with the system. The FARAWAVE catheter is used to treat a range of pulmonary vein anatomies using an over-the-wire catheter with variable basket and flower shapes, allowing the device to adapt to individual patient anatomies. These configurations reinforce ease-of-use for physicians and promote reproducible procedures between operators.
Boston Scientific completed enrollment in the first phase of the ADVANTAGE AF clinical trial in the third quarter of 2023, which is studying the system for the treatment of patients with drug-refractory, symptomatic, persistent AF, and commenced enrollment in a second phase of the study to evaluate the safety and effectiveness of adjunctive use of the FARAPOINT™ PFA Catheter for cavotricuspid isthmus (CTI) ablations, a procedure used to treat atrial flutter. The company also recently commenced the AVANT GUARD clinical trial to evaluate the safety and efficacy of the system as a first-line treatment for persistent AF compared to anti-arrhythmic drug therapy.
The FARAPULSE PFA System was granted Breakthrough Device Designation from the Center for Devices and Radiological Health (CDRH) of the U.S. FDA in 2019 and received CE Mark in 2021. Boston Scientific plans to immediately launch the system in the U.S. The company is developing a navigation-enabled version of the FARAWAVE catheter alongside the FARAVIEW™ Software Module and anticipates regulatory approval in 2024.
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions.
SOURCE Boston Scientific Corporation
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