RenovoRx Receives CE Mark for RenovoCath™Novel Double-Balloon Catheter Will Soon be Commercially Available in Europe
RenovoRx Receives CE Mark for RenovoCath™
RenovoRx, a leading developer of innovative solutions for targeted delivery of fluids to selected sites in the peripheral vascular system, today announced that the company achieved the CE Mark for commercial sale of the RenovoCath™. The catheter will offer EU physicians a new tool for targeted delivery of fluids.
“Achieving the CE Mark for the RenovoCath™ will enable us to provide our innovative device to physicians and patients in the European Union,” said Shaun Bagai, Chief Executive Officer of RenovoRx. “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.”
“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,” said Klaus Hambeuchen, RenovoRx board member, healthcare start-up investor and advisor.
The RenovoCath received FDA clearance in late 2014. The RenovoCath 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. The innovative 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 effectiveness of treatment and reduce side effects.