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Home » Atricure scores win at FDA with atrial fibrillation solution
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Atricure scores win at FDA with atrial fibrillation solution

April 29, 2021
By Meg Bryant
Atricure Inc. has received the green light from the FDA for its Epi-Sense guided coagulation system with Visitrax technology to treat patients diagnosed with long-standing, persistent atrial fibrillation (AF). The device was previously cleared via a 510(k) for the coagulation of cardiac tissue, and is already available in the U.S. The FDA approval represents the first and only minimally invasive ablation therapy for the more than 3 million Americans with longstanding AF.
BioWorld MedTech Regulatory Cardiovascular U.S. 510(k) FDA

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