A Unique Alternative to Standard-of-Care Thermal Ablation
Manatee Memorial Hospital is now offering the FARAPULSE™ Pulse Field Ablation System as an alternative to standard thermal ablation.
About the FARAPULSE™ Pulsed Field Ablation System
The FARAPULSE PFA System is a unique new alternative to standard-of-care thermal ablation. A non-thermal approach for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation (AF), it is proven to be an effective treatment option for patients while minimizing risks associated with thermal ablation.
During a traditional ablation procedure, a catheter is guided to the interior of the heart and generates extreme temperatures – hot or cold – to destroy targeted areas in the heart associated with abnormal heart rhythms. The FARAPULSE PFA System, however, relies on tissue selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures.
Positive 12-month data from the pivotal ADVENT clinical trial – the first randomized clinical trial to directly compare the efficacy and safety of the system against standard-of-care ablation – found that therapy with the device was as safe and effective as conventional thermal ablation, with statistically shorter ablation times and a quicker learning curve for physicians. Additional real-world data from more than 17,000 patients in the MANIFEST-17K registry demonstrated continued real-world safety of the system, with no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury.
About Atrial Fibrillation
Atrial fibrillation (AF) occurs when the top two chambers of the heart, the atria, beat too fast and with an irregular rhythm (fibrillation). AF, the most common type of arrhythmia, can decrease the heart’s pumping efficiency, which can cause blood cells to pool and stick together, forming clots in the heart, and lead to stroke. People with AF have a higher risk of stroke, heart failure and other heart-related complications than those with normal heart rhythms. AF affects nearly two percent of the general population worldwide[1], and approximately seven million Americans live with this arrhythmia. An estimated 38 million people globally have AF.[2]
[1] Camm JA et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation, European Heart Journal 2012, 33:2719–2747
[2] Colilla S, Crow A et al. Estimates of Current and Future Incidence and Prevalence of Atrial Fibrillation in the U.S. Adult Population. Am J Cardiol 2013;112:1142-1147.