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RenovoRx’s catheter receives FDA 510(k) approval

RenovoRx has obtained 510(k) approval from the US Food and Drug Administration for its RenovoCath RC120 catheter.

The catheter has been developed for the isolation of blood flow and delivery of fluids, including diagnostic material and therapeutic agents, into selected sites in the peripheral vascular system utilizing a dual balloon occlusion design.

RenovoRx Advisory board member David Madoff said: "Intra-arterial delivery of drugs like chemotherapy show significant promise for the management of difficult to treat diseases. To my knowledge, the RenovoRx device is the ideal catheter for targeted delivery of therapy to sites in the visceral and peripheral vasculature."

The catheter features dual occlusion design, which helps physicians to target selected sites in the vasculature for accurate delivery of therapeutic and diagnostic agents.

RenovoRx CEO Shaun Bagai said: "We are delighted to receive FDA clearance for the RenovoCath RC120.

"We can now introduce our novel catheter to the clinical market, which will allow physicians to deliver diagnostic and therapeutic agents exactly where they want them."

Based in California, RenovoRx is an early stage startup that develops solutions for the isolation of blood flow and delivery of fluids.