FDA Clears Acutus Medical AcQCross Suite of Transseptal Cros

FDA Clears Acutus Medical AcQCross Suite of Transseptal Crossing Devices


FDA Clears Acutus Medical AcQCross Suite of Transseptal Crossing Devices
Product family targets electrophysiology and structural heart procedures
April 14, 2021 — The U.S. Food and Drug Administration (FDA) cleared the Acutus Medical AcQCross family of universal transseptal crossing devices. This is the only transseptal puncture system specifically engineered to pair and mate seamlessly with Acutus’ own suite of sheaths and with sheaths sold by other manufacturers. 
In the United States, there are over 300,000 electrophysiology (EP) and structural heart procedures per year involving the use of transeptal crossing devices.[1,2,3] The company will initiate its full U.S. commercial launch of AcQCross in the coming weeks.

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