RenovoRx has received CE mark approval for its RenovoCath catheter, allowing the firm to provide EU physicians with a new tool for targeted delivery of fluids.
In late 2014, the firm received 510(k) approval from the US Food and Drug Administration for the RenovoCath RC120 catheter.
RenovoCath was 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.
Design of the catheter enables clinicians to deliver diagnostic and therapeutic agents to the visceral and peripheral vascular system to provide precise and controlled infusion of fluids to targeted regions.
RenovoRx CEO Shaun Bagai said: "Achieving the CE Mark for the RenovoCath will enable us to provide our innovative device to physicians and patients in the European Union.
"There are early indicators of demand for our device in Europe, and we are now finalizing our plans for a phased commercial launch at select European sites."
RenovoRx board member Klaus Hambeuchen said: "The EU medical device market accounts for one-third of the global market, and the CE Mark certification grants RenovoRx access to more than 30 European countries and an aging population of more than 500 million with increasing healthcare needs."
Based in California, RenovoRx is an early stage startup that develops solutions for the isolation of blood flow and delivery of fluids.