Baxter International Inc. BAX recently received the FDA’s 510(k) clearance for its ST Set used in continuous renal replacement therapy (“CRRT”). The system is expected to offer additional options to provide CRRT for patients in an acute care environment.
The ST Set, a pre-connected, disposable, extracorporeal (outside the body) circuit, offers blood purification via a semi-permeable membrane and is to be used with the PrisMax or Prismaflex control units (monitors). It has been available to U.S. customers since August 2020 after the receipt of the FDA’s Emergency Use Authorization to provide CRRT to treat patients in an acute care environment during the pandemic. Presently, the ST Set is being used across countries in Europe, Asia Pacific, and North and South America.
With the latest regulatory clearance, Baxter’s Renal Care business is expected to gain a solid foothold in the global arena.