February 6, 2009 - Biosense Webster Inc., a Johnson & Johnson company, today said the FDA granted market approval to the NaviStar ThermoCool Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible 3D electroanatomic mapping systems.
Atrial fibrillation, or AFib, is a highly prevalent heart rhythm disorder and one of the most common causes of stroke.
On Nov. 20, 2008, the FDA’s Circulatory System Devices Panel unanimously recommended approval of the NaviStar ThermoCool Catheter for AFib. It is first and only ablation catheter in the U.S. to be approved for the treatment of this disorder, which affects an estimated 10 million people worldwide.
Conditions of approval include a post-marketing registry and a physician education program about use of the product.
The NaviStar ThermoCool Catheter is also approved in the U.S. 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.
Today’s approval is 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 drug refractory recurrent symptomatic paroxysmal AFib. These data were first presented in November 2008 at the American Heart Association’s Annual Scientific Sessions.
Patients receiving cardiac ablation with the NaviStar ThermoCool Catheter 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 percent for patients receiving NaviStar ThermoCool Catheter ablation at end of the nine-month effectiveness evaluation period, which is significantly superior to the 17.2 percent probability for the group of patients treated with AAD. The NaviStar ThermoCool Catheter ablation group also demonstrated a dramatic reduction in symptomatic AFib recurrence compared with patients treated with AAD (75 vs 21 percent).
Additionally, the catheter ablation group demonstrated an excellent safety profile with no device-related serious adverse events such as death, heart attack, stroke, cerebrovascular accident, heart block or atrial perforation within seven days post ablation. Importantly, there was no clinically significant pulmonary vein stenosis in patients receiving ablation, and the incidence of serious adverse events in the NaviStar ThermoCool Catheter group in the 90 days following initiation of therapy was observed to be approximately half that in the AAD group (35.1 vs. 18.4 percent). Biosense Webster sponsored this trial.
Today’s approval by the FDA also includes the EZ Steer ThermoCool Navigational Catheter, which is a bi-directional version of the catheter. These catheters are compatible with 3D mapping systems that recognize the Carto System magnetic location sensors.
For more information: www.biosensewebster.com
April 24, 2024 
