"The U.S. approval of the POLARx Cryoablation System, which has been used in more than 25,000 patients worldwide to date, marks an exciting advancement for the treatment of AF and a new era of cryoablation capabilities," said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. "By prioritizing procedural flexibility and individualized care, this offering transforms a key therapy in the electrophysiology space, addresses the unmet needs of physicians and affirms our commitment to making meaningful innovations to established technologies."
The POLARx Cryoablation System received CE Mark in February of 2020 and Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval in October of 2021. The POLARx FIT catheter received approval in Europe, Japan, Canada and other Asia Pacific markets in 2023.
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About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
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