Tumor Embolization Using A Novel Catheter With Integrated Flow Regulation

ABSTRACT Worldwidethere is a growing incidence of cancer with a present annual number of diagnosed cases at aboutMInthe NCI estimates that in the USnew cancers will be diagnosed that result indeathsStandard chemotherapy is often ineffective and is known for its numerous toxic side effectsEmbolization therapy is highly selective to a particular tumorwhereby anti cancer agents are largely confined within the tumorCurrent delivery devices are inadequateresulting in incomplete tumor fillingnon target delivery to healthy tissuesirreproducibilityand failure of the technique to reach its full efficacy potentialPresentlyembolization therapy is largely limited to tumors of the liverThe objective of the present Phase II project is to substantially improve the efficacy and reproducibility of this technique and deliver a product to the market in relatively short period of time that expands embolization therapy to many cancersoffering lifesaving efficacy and dramatic improvements in the quality of lifeThrough hemodynamic studiesthe company elucidated a mechanism whereby blood flow redistributionenabled by a lowering of pressure in the vicinity of the tumorresults in embolic agents to preferentially flow into the tumorThe present Phase II proposal includes the design and implementation of a balloon microcatheter with integrated pressure microsensorThe unique partial occlusion balloon implements the required pressure reduction and includes flow through channels that allow a small blood bypass of aboutto wash anti tumor agents from the infusion point to the tumorThe pressure sensor provides real time pressure monitoring allowing embolization to be charted and optimized in real time and include a quantitative endpointExisting microsensors will be modified and integrated at a position distal to the occlusion balloonIn parallelthe balloon will be optimized to the desired flow through velocity and pressure reduction range of ammHg in the vascular space distal to the balloonThe catheter will be optimized to specifications required for clinical use including an outer diameter of less thanmmexcellent tracking through torturous vasculaturecompatibility with common reagents and balloon inflation deflation times of less thansecondsThe pressure sensorcatheterand partial occlusion balloon will be integrated and assembled consistent with a manufacturing environmentBench and animal testing will comply with FDA and CE requirements and will be included in a regulatory filing at the end of the Phase II periodAn animal tumor model will be completed using a rabbit VXliver carcinomaThis model is well characterized and has been used in tumor embolization studiesThe primary endpoint is to demonstrate that embolization at a low pressurevia partial occlusionimproves chemotherapeutic distributionand tumor responsenecrosisSecondary objectives include correlation of pressure to tumor response and demonstrating a pressure mediated quantitative endpointThis study will be helpful in marketing the device following the Phase II period NARRATIVE Worldwidethere is a growing incidence of cancer with the annual number of diagnosed cases at aboutMMStandard chemotherapy is often ineffective and the tumor embolization has numerous shortcomings that limit its useThe present project proposes a revolutionary method and device to dramatically improve efficacy and reproducibility of embolization therapyexpand utility to many primary tumorsimprove patient accessextend lifeand even lead to long term remission