Ablation catheter for persistent AF receives FDA approval
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Johnson & Johnson Medical Devices Companies and Biosense Webster announced that an ablation catheter to treat patients with persistent atrial fibrillation has been approved by the FDA.
Approval of the catheter (Thermocool Smarttouch SF, Biosense Webster) was based on findings from the PRECEPT study. As Healio previously reported, the PRECEPT study found that ablation with a porous tip contact force-sensing catheter was safe and effective in patients with persistent AF.
“Every patient and every arrhythmia are unique,” Francis Marchlinski, MD, director of electrophysiology at the University of Pennsylvania Health System, said in the release. “This approach and the PRECEPT data provide evidence to support a tailored approach using the Carto 3 system and Thermocool Smarttouch SF catheter to treat persistent AF patients who are more at risk for stroke and other complications from their AF.”
In the PRECEPT study, 381 patients were enrolled from 27 sites with symptomatic persistent AF, according to Healio’s coverage of the presentation at the virtual Heart Rhythm Society Annual Scientific Sessions. There was a safety population (n = 348; mean age, 65 years; 71% men) and an effectiveness population (n = 333; mean age, 65 years; 71% men). All patients underwent pulmonary vein isolation with ablation using a porous tip contact force-sensing catheter.
Researchers in the PRECEPT study observed 14 primary adverse events in 13 patients, which equaled a rate of 3.8%, allowing the study to meet its primary safety endpoint. The primary effectiveness endpoint was also met. Based on Kaplan-Meier analyses, the primary effectiveness success rate was 61.7%. In addition, the clinical success rate, which is a more relevant clinical measure in persistent AF, was 80.4% at 15 months.
The procedure with this catheter also resulted in an improvement in quality of life at 15 months, according to the release.
“Persistent AF patients face a higher risk of complications such as stroke, heart failure and death,” Uri Yaron, worldwide president of Biosense Webster, said in the release. “This approval and data from the PRECEPT study help to further our commitment to advancing AF treatment, providing electrophysiologists with state-of-the-art options for their patients.”
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