FDA Advisory Panel Unanimously Recommends Approval Of NAVISTAR(R) THERMOCOOL(R) Catheter For Atrial Fibrillation
April 16, 2018
Biosense Webster, Inc., a Johnson & Johnson company, today reported the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) unanimously recommended approval of the Company's Pre-Market Approval (PMA) supplement for the NAVISTAR® THERMOCOOL® Catheter for the treatment of symptomatic paroxysmal atrial fibrillation. The NAVISTAR® THERMOCOOL® Catheter is the first ablation catheter to be recommended by the panel for FDA approval.
Atrial fibrillation, or AFib as it is more commonly referred to, is the most prevalent cardiac arrhythmia (heart rhythm disorder) and one of the most common causes of stroke.
"We are pleased with the recommendation for approval and will work closely with the Agency to bring this important new option to patients with AFib as quickly as possible," said Shlomi Nachman, Worldwide President, Biosense Webster, Inc.
Conditions for approval recommended by the review panel include a post-marketing registry and a physician education program about use of the product.
Currently, there are no ablation catheters approved for marketing by the FDA for the treatment of AFib in the United States. Biosense Webster requested expanding the current label for the NAVISTAR® THERMOCOOL® Catheter to include an indication for drug refractory symptomatic paroxysmal AFib. The NAVISTAR® THERMOCOOL® Catheter is currently approved in the United States for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction (heart attack). Atrial flutter and ventricular tachycardia are two types of cardiac arrhythmia.
Clinical Data Presented to the Panel
Today's unanimous recommendation was based on results from a multicenter study comparing catheter ablation to drug therapy for the treatment of AFib. In this randomized clinical trial, catheter ablation was shown to significantly outperform anti-arrhythmic drug (AAD) therapy for the treatment of symptomatic paroxysmal AFib. These data were first presented at the recent American Heart Association's Annual Scientific Sessions.
Patients receiving cardiac ablation with the NAVISTAR® THERMOCOOL® Catheter, manufactured by Biosense Webster, Inc., were significantly more likely to be free of recurring AFib and experienced fewer serious adverse events than those receiving AAD therapy.
This clinical trial was a randomized, unblinded and controlled evaluation of symptomatic, paroxysmal AFib patients who were refractory to at least one AAD and had at least three episodes of AFib in the six months prior to randomization. A total of 167 patients were enrolled from 19 sites throughout the world and the primary effectiveness endpoint (chronic success) was freedom from documented symptomatic AFib recurrence following procedural endpoint confirmation and absent new AAD use or repeat ablation outside of protocol-defined criteria.
The probability of chronic success was 62.7% for patients receiving NAVISTAR® THERMOCOOL® Catheter ablation at end of the 9-month effectiveness evaluation period, which is significantly superior (p