The National Health Surveillance Agency (ANVISA) approved new technology for treating atrial fibrillation. Boston Scientific Brasil’s innovative pulsed field ablation (PFA) system offers a safe and effective alternative for around 1.5 million Brazilians affected by atrial fibrillation annually, 70% of whom experience symptoms. , as confirmed by studies by the Brazilian Society of Cardiology (SBC). The technology has already demonstrated success in more than 40,000 patients on a global scale.
Treatment aims to interrupt recurrent episodes of arrhythmia, preventing progression to persistent and permanent forms, which can cause serious cardiac complications, including heart failure and an increased risk of adverse cardiovascular events, such as heart attack and stroke.
“The approval is an important milestone in helping millions of people who are affected by atrial fibrillation in Brazil, as well as being an incredible opportunity to bring the first PFA system designed and built exclusively for this type of ablation therapy”, says Kalyne Terumi Chagas , director of the Heart Rhythm area at Boston Scientific Brasil.
Treatment differences
Unlike traditional ablation methods, which employ extreme temperatures to destroy specific areas of heart tissue, the new system uses electrical fields to selectively target the cells responsible for the arrhythmia, minimizing the risk of damage to adjacent structures, such as the esophagus and phrenic nerve. .
A retrospective study, called MANIFEST 17K, conducted in more than 106 centers around the world, involving more than 17 thousand patients, validated the safety of the treatment, recording rates of esophageal injury, permanent phrenic nerve damage and pulmonary vein stenosis of 0%. Furthermore, the ADVENT study, carried out in 30 centers in the United States, proved that the system achieved efficacy comparable to thermal energy in the treatment of atrial fibrillation, demonstrating its safety and effectiveness.
