Menlo Park, CA (October 30, 2014) – RenovoRx, a leading developer of innovative solutions for targeted delivery of fluids to selected sites in the vascular system, today announced the company has received FDA 510(k) clearance of its flagship product, the RenovoCath RC120 catheter.
The RenovoCath RC120 catheter (510k Number K141175) is specifically 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. 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 uniquely designed two-part handle for maximum control. The innovative design will allow 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 effectiveness of physician-defined treatment and reduce side effects.
"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," said David Madoff, MD, Professor of Radiology and Chief of Interventional Radiology at New York Presbyterian/Weill Cornell Medical Center and RenovoRx Advisory Board Member. "I expect that interventionalists will be eager to use this device to treat their patients."
The dual occlusion design is unique and could be advantageous over the single occlusion or fixed balloons on the market today that do not provide physicians the flexibility to target selected sites in the vasculature for accurate delivery of therapeutic and diagnostic agents.
"We are delighted to receive FDA clearance for the RenovoCath RC120," said Shaun Bagai, Chief Executive Officer. "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."