DELRAY BEACH, Fla. – Delray Medical Center is the first hospital in Palm Beach County to offer the FARAPULSE™ Pulsed Field Ablation System, a newly approved device for the treatment of atrial fibrillation, the most common type of heart arrhythmia. The first procedure using the new system was performed at the hospital by Dr. Yoel Vivas on April 2nd, 2024.

The FARAPULSE PFA System, which is manufactured by Boston Scientific, received approval from the U.S. Food and Drug Administration in January.ⁱ The new system offers an alternative treatment for atrial fibrillation than traditional thermal ablation, in which a catheter placed in the interior of the heart generates extreme temperatures – hot or cold – to destroy targeted areas in the heart associated with abnormal heart rhythms. Instead, the FARAPULSE PFA System relies on tissue-selective, non-thermal electric fields to ablate heart tissue and avoid damage to surrounding structures.

Atrial fibrillation occurs when the top two chambers of the heart, the atria, beat too fast and with an irregular rhythm (fibrillation). It 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 atrial fibrillation have a higher risk of stroke, heart failure and other heart-related complications than those with normal heart rhythms.ⁱⁱ

“We are excited to be able to provide our patients with this new treatment option for atrial fibrillation that is designed to minimize risks associated with thermal ablation,” said Daniel Listi, Delray Medical Center’s CEO. "This application of PFA is the first of its kind in the world. We have been very excited about what Boston Scientific's innovations with FARAPULSE will offer beyond any existing technologies. It’s finally here for our community and we are proud to be Boston Scientific’s first choice in Palm Beach County."

According to Boston Scientific, 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.ⁱⁱⁱ

The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the U.S. will have atrial fibrillation in 2030. iv The increased prevalence of atrial fibrillation in the population is believed to result from the aging of the population, improvements in coronary care, and the rising prevalence of risk factors such as diabetes.^v