FDA Clears RenovoCath RC120 Catheter for Targeted Delivery of Fluids to Peripheral Vascular System

October 30, 2014—RenovoRx announced that it has received US Food and Drug Administration 510(k) clearance of the RenovoCath RC120 catheter, which is designed 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. 

According to the company, the proximal and distal occlusion balloons help isolate the vascular site while allowing infusion of fluids in a controlled environment. The two balloons are inflated and positioned independently using the catheter’s two-part handle for maximum control. The design allows clinicians to deliver diagnostic and therapeutic agents to the visceral and peripheral vascular system to provide precise, controlled infusion of fluids to targeted regions, which may potentially increase the effectiveness of physician-defined treatment and reduce side effects.  

In the company’s press release, interventional radiologist David Madoff, MD, commented, “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. I expect that interventionists will be eager to use this device to treat their patients.” Dr. Madoff is Professor of Radiology and Chief of Interventional Radiology at New York Presbyterian/Weill Cornell Medical Center in New York, New York. Dr. Madoff also serves as a RenovoRx Advisory Board Member.