FlowMedica, Inc., of Fremont, Calif., announced that it has received clearance for a new labeling indication for its Benephit Infusion Systems, which can now facilitate targeted renal therapy (TRT) in patients who have demonstrated symptoms of or are at risk of developing acute kidney injury (AKI).
Since TRT facilitates direct infusion of medications and other therapeutic agents via the renal arteries into both kidneys at the same time, it may offer significant benefit over IV infusion by allowing local delivery with reduced systemic side effects.
Target patient populations include those with coronary artery disease, peripheral arterial disease, or a coronary artery bypass graft. The Benephit systems are indicated for use in patients undergoing medical, interventional, or surgical procedures with an elevated risk of iatrogenic kidney injury, as well as in patients who have demonstrated AKI symptoms.
Both the Benephit CV and XT Infusion Systems consist of a bifurcated infusion catheter and a vascular introducer sheath with dilator.