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Biosense Webster Receives FDA Approval For Atrial Fibrillation Device

Biosense Webster, Inc. announced that its NaviStar ThermoCool Catheter desgined to treat drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems received FDA approval. “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.” The NaviStar ThermoCool is the initial device to get FDA approval for the treatment of this disorder, which affects approximately 10 million people worldwide. It is also approved for the treatment of Type 1 atrial flutter, and recurrent drug or device refractory sustained monomorphic ventricular tachycardia due to prior myocardial infarction. “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.”