Introducing the RenovoCath Device
Designed for Targeted Diagnostic & Therapeutic Agent Delivery

Designed for Targeted Diagnostic & Therapeutic Agent Delivery
Please see the full FDA-cleared intended use statement below.*
RenovoCath is a patented, FDA-cleared delivery system enabled by an adjustable, dual balloon catheter with intermittent occlusive capabilities. RenovoCath enables physicians to isolate sections of the blood vessel through the adjustment of the distance between the occlusion balloons, thereby excluding any off-target side branches and/or including tumor feeders.
Studying The Potential of RenovoCath: How it May Work Outside the Arterial Wall**
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*RenovoCath is currently cleared for the indication below. The Company is evaluating its novel combination oncology product candidate (intra-arterial gemcitabine, known as IAG) in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of FDA) under a U.S. investigational new drug application that is regulated by the FDA’s 21 CFR 312 pathway. Based on completed studies, intra-arterial delivery of chemotherapy via Trans-Arterial Micro-Perfusion (TAMP™), which targets delivery of treatment in proximity to the tumor tissue within the pancreas using the vasa vasorum pathway, reduced tolerability issues associated with systemic chemotherapy and presented early signals of improved patient survival. The study, called TIGeR-PaC (“Intra-Arterial Gemcitabine vs. IV Gemcitabine and Nab-Paclitaxel Following Radiotherapy for LAPC”), and the combination oncology product candidate (IAG) is not yet cleared or approved by FDA for this use and not yet available for commercial sale.
Thank you for your interest in the RenovoCath delivery system intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion.
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