Timing is everything. Just days after confirming a pause in the U.S. rollout of its Varipulse pulsed field ablation (PFA) catheter, Johnson & Johnson’s electrophysiology program received an epic reprieve from European regulators who granted the company’s dual-energy Thermacool Smarttouch SF catheter CE mark.
Biosense Webster Inc. reported U.S. FDA approval of its Thermocool Smarttouch SF ablation catheter for the treatment of patients with persistent atrial fibrillation (persistent AF). This follows results of the prospective, multicenter Precept study, which showed the catheter to be safe and effective for 80% of patients over 15 months of ablation therapy with clinically meaningful improvement in quality of life.