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FDA Grants Marketing Approval To NAVISTAR THERMOCOOL Catheter For Atrial Fibrillation

Biosense Webster, Inc. announced that the US FDA has granted marketing approval to the NAVISTAR THERMOCOOL Catheter for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. On November 20, 2008, the FDA’s Circulatory System Devices Panel unanimously recommended approval of the NAVISTAR THERMOCOOL Catheter for AFib. The NAVISTAR THERMOCOOL Catheter is the novel ablation catheter in the US to be approved for the treatment of this disorder. “Today’s announcement is a milestone for electrophysiologists, physicians who specialize in heart rhythm disorders, and their patients throughout the US,” said Marcia S. Yaross, Ph.D., Vice President, Clinical, Regulatory and Health Policy, Biosense Webster. “This landmark decision by the FDA recognizes the safety and effectiveness of NAVISTAR THERMOCOOL Catheter ablation for the treatment of paroxysmal AFib and gives the medical community another treatment option for many patients whose often debilitating symptoms are not effectively managed through medical therapy.” 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 US for the treatment of Type 1 atrial flutter, and recurrent drug/device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction (heart attack). “Since it was founded, Biosense Webster has been a leading provider of innovative products for the treatment of heart rhythm disorders and continues to partner with electrophysiologists to help advance ablation options for the millions of patients with these conditions,” said Shlomi Nachman, Worldwide President, Biosense Webster. “Today’s approval continues our legacy of innovation.” The 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. 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