J&J’s Biosense Webster Gets FDA Nod for Ablation Catheter for AFib

Johnson & Johnson Medical Devices Companies announced the United States Food and Drug Administration (FDA) approval of Biosense Webster Inc.’s THERMOCOOL SMARTTOUCH SF Ablation Catheter for the treatment of persistent atrial fibrillation (persistent AF).† The approval is based on results of a prospective, multi-center study (PRECEPT) which met primary safety and effectiveness endpoints and demonstrated 80 percent of persistent AF patients experienced clinical success at 15 months after ablation therapy using the THERMOCOOL SMARTTOUCH SF Catheter with the CARTO VISITAG Module.‡1,2 In addition, patients experienced clinically meaningful improvement in quality of life and the study showed significant reduction in healthcare resource utilization post-ablation.^1,2
 
Atrial fibrillation (AF) is a significant public health issue affecting the health of millions of people and placing a critical burden on healthcare systems. Persistent AF is defined as continuous AF that lasts for more than seven days and up to one year. The management of persistent AF aims to prevent AF recurrence and associated disabilities while reducing side effects from treatment.

“Every patient and every arrhythmia are unique,” said Dr. Francis Marchlinski, Director of Electrophysiology, University of Pennsylvania Health System. “This approval 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.”
 
The PRECEPT study is the first prospective, multi-center investigational device exemption study designed to evaluate the safety and effectiveness of radiofrequency (RF) catheter ablation in patients with persistent AF, and was conducted using the THERMOCOOL SMARTTOUCH SF Catheter. Results of the PRECEPT study demonstrated 80 percent of persistent AF patients experienced clinical success at 15 months after ablation therapy and 86 percent experienced freedom from repeat procedures at 15 months.³ The CARTO 3 System and THERMOCOOL SMARTTOUCH SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in a more advanced persistent AF patient group (continuous AF > 7 days < 1 year).*²
 
Radiofrequency ablation with the THERMOCOOL SMARTTOUCH SF Catheter led to a clinically meaningful improvement in Quality of Life (QOL), as well as a reduction in antiarrhythmic drug (AAD) use, cardioversion and hospitalization in persistent AF patients.§³
“Persistent AF patients face a higher risk of complications such as stroke, heart failure, and death,” said Uri Yaron, Worldwide President of Biosense Webster Inc. “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.”
 
The PRECEPT study enrolled a total of 381 patients with documented symptomatic persistent AF who did not respond or were intolerant of one or more AADs (Class I or III). The study was conducted at 27 sites across the United States and Canada.¹ The primary effectiveness endpoint was freedom from documented recurrence of atrial flutter/atrial tachycardia episodes of 30 seconds or longer and freedom from additional five failure modes: acute procedural failure, use of a non-study catheter, repeat procedures, use of new/higher dose antiarrhythmic drugs, surgical AF ablation.¹ A tailored ablation strategy was used, allowing for pulmonary vein isolation (PVI) and additional left atrial ablations (PVI+) at the operator’s discretion based on the patient’s disease state.¹ The study resulted in a 4.7 percent primary adverse event (PAE) rate which is comparable to PAE rates reported in paroxysmal AF studies using CF-sensing RF catheters.^4,5,6
 
*In a prospective, multicenter study (PRECEPT, n=333) protocol defined primary effectiveness was the freedom from documented AF/AT/AFL recurrence ≥30 s.
† The THERMOCOOL SMARTOUCH SF Catheter is indicated for drug refractory recurrent symptomatic persistent atrial fibrillation (AF) (continuous AF > 7 days but < 1 year), refractory or intolerant to at least 1 Class I or III AAD, when used with the CARTO® 3 System.
‡ In a prospective, multicenter study (PRECEPT, n=333) where clinical success is defined as freedom from documented symptomatic AF/AT/AFL recurrence.
§ In a prospective, multicenter study (PRECEPT, n=333), improvements based on mean AFEQT composite and subscores seen from 6– 15 months, exceeding Clinically Important Difference (±5 points). Class I/III AAD use was reduced from 97 percent to 25 percent, incidence of cardioversion decreased from 62 percent to 10 percent, and the 15–month Kaplan–Meier estimate of freedom from hospitalization was 84 percent.
 
References
¹ Mansour M, Calkins H, Osorio J, et al. Persistent atrial fibrillation ablation with a contact force sensing catheter: the prospective multicenter PRECEPT trial. Presented at: Heart Rhythm Society Scientific Session Virtual Meeting; May 2020.
² Mansour M, Calkins H, Osorio J, et al. Persistent Atrial Fibrillation Ablation with Contact Force–Sensing Catheter. J Am Coll Cardiol EP. 2020 Aug, 6 (8) 958-969.
³ Natale A, Calkins H, Osorio J, et al. (2020). Positive Clinical Benefit on Patient Care, Quality of Life and Symptoms After Radiofrequency Ablation with Contact Force in Persistent Atrial Fibrillation: Analyses from PRECEPT. Poster presentation at the European Society of Cardiology Scientific Session, August 29 – September 2, 2020.
⁴ PRECEPT IDE G140102.
⁵ Natale A, Reddy VY, Monir G, et al. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014;64(7):647-656.
⁶ Chinitz LA, Melby DP, Marchlinski FE, et al. Safety and efficiency of porous-tip contact-force catheter for drug-refractory symptomatic paroxysmal atrial fibrillation ablation: results from the SMART SF trial. Europace. 2018;20(FI_3):f392-f400.