This article is more than 5 years old. Information may no longer be current.
FDA approves ablation catheter for treatment of certain arrhythmias
Click Here to Manage Email Alerts
Biosense Webster announced that the FDA has approved its ThermoCool SmartTouch ablation catheter for the treatment of patients with drug-resistant paroxysmal atrial fibrillation, sustained monomorphic ischemic ventricular tachycardia or Type I atrial flutter.
The device is the first FDA-approved therapeutic catheter enabling direct and real-time measurement of contact force during catheter ablation procedures for those patient populations, according to a company press release.
Approval was based on the results of the prospective, multicenter SMART-AF trial, which indicated an overall success rate of 74% for the catheter at 1 year, and a success rate at 1 year of 88% when physicians stayed within a targeted range at least 85% of the time, according to the press release.
The catheter “will enable us to more precisely control the amount of contact force applied to the heart wall when creating lesions during catheter ablation,” Andrea Natale, MD, primary investigator of the SMART-AF trial and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Austin, Texas, said in the release. “Data from the SMART-AF trial demonstrated that consistent and stable application of contact force has a significant impact on patient outcomes. The use of contact force-sensing technology has emerged as a critical tool in delivering optimal outcomes in the treatment of patients with AF and represents a major advancement for the clinical community.”