RenovoRx today said it received FDA 510(k) clearance for its RenovoCath delivery system.
Los Altos, California-based RenovoRx designed the RenovoCath system as the device component for its RenovoGem chemotherapy drug. The combined drug/device RenovoTAMP trans-arterial micro-perfusion therapy is a dual-balloon infusion catheter that delivers chemotherapy directly to tumors through the arteries.
The new RenovoCath design has a more targeted delivery of therapy for more effective treatment with fewer side effects. RenovoRx initially received FDA clearance for the delivery system in 2014.
“Our novel RenovoTAMP therapy platform isolates the region of disease enabling delivery of the optimal dose of targeted chemotherapy to the tumor location,” CEO Shaun Bagai said in a news release. “We believe this new design cleared through the FDA 510(k) process will further improve RenovoTAMP’s targeted delivery. Our focus is maximizing patient survival while minimizing side effects for cancer patients.”
RenovoTAMP is currently under clinical investigation for increasing survival and improving quality of life. The company suggests the system could enable physicians to isolate the anatomy and micro-perfuse targeted tissue with small molecule chemotherapy.
