Boston Scientific Receives FDA Approval for the POLARx™ Cryoablation System
MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System. The new system, which is indicated for the treatment of patients with paroxysmal atrial fibrillation (AF), features the POLARx FIT Cryoablation Balloon Catheter, a device with the unique capability of enabling two balloon sizes – 28 and 31mm – in one catheter.
- First-of-its-kind expandable cryoballoon catheter advances cryoablation therapy, addresses key limitations with traditional systems
MARLBOROUGH, Mass., Aug. 8, 2023 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the POLARx™ Cryoablation System. - "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.
- 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.