Roivios wins FDA breakthrough nod for renal assist device

The JuxtaFlow renal assist device system features a catheter (left) and pump (right). [Image from the Roivios Website]Roivios announced today that it received FDA breakthrough device designation for its JuxtaFlow renal assist device (RAD).

The Bahamas-based medical device company designed JuxtaFlow to improve treatments for patients facing kidney disease during cardiac surgery. JuxtaFlow uses a unique, gentle negative pressure technique on the kidneys’ urine-collecting system. It enhances function and shield against hypoxia-induced damage under acute conditions.

JuxtaFlow combines a catheter and pump system. A trained urologist inserts the catheters in a manner similar to ureteral stent placement. Then, the catheter connects to the pump to deliver the negative pressure. Roivios designed the negative pressure to transmit through the nephrons, reducing downstream hydrostatic pressure. Controlled pressure reduction allows for effective filtration and selective …

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