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Biotech / Medical : Future Medical Device Companies

STXS 2.920

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Oct 29 3:59 PM EDT

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To: semi_infinite who wrote (123)	11/20/2008 11:53:17 PM
From: twy88	of 136

GAITHERSBURG, Md.--(BUSINESS WIRE)--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.

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