Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use (IFU) labeling for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The updated labeling now includes approval for the system in the treatment of drug refractory, symptomatic persistent atrial fibrillation (AF), an arrythmia in which the heart beats abnormally for at least seven days.
AF affects an estimated 59 million people worldwide and many have the persistent form of the condition, which can cause dizziness, fatigue, shortness of breath and increase the risk of stroke.
The FARAPULSE PFA System treats AF by delivering pulsed field energy through a catheter to ablate heart tissue. This approval updates the IFU for both the FARAWAVE™ PFA Catheter and the FARAWAVE NAV™ PFA Catheter to include treatment for patients with persistent AF.
"Backed by clinical evidence and our global commercial experience, this update advances our efforts to further shape the future of AF treatment with safe and effective ablation technologies," said Brad Sutton, M.D., chief medical officer, AF Solutions, Boston Scientific.
"We look forward to studying the system in new clinical trials, including patients in need of re-do ablations and those with more complex arrhythmias, which account for a large portion of the procedures today still using thermal ablation."
BSX shares dropped five cents to $104.27.
