Recently, drug coated balloons (DCB) have emerged as a promising alternative for treating stenosed arterial vessels. The demonstrated efficacy of DCB is tempered by the risk of distal arterial embolism, which can result from systemic drug exposure caused by premature dissolution or delamination of the drug coating into the blood stream during catheter insertion and guidance. This """"""""wash-off"""""""" effect is dependent on the length of time the catheter is within the body, therefore varies considerably from procedure to procedure. An unknown, but significant amount is washed off and distributed into the bloodstream. As a result, the drug dosage administered to the affected vessel is difficult to quantify leading, thus, resulting in inconsistent clinical results. There is a pressing need for a minimally invasive device that provides controlled and reproducible local drug delivery while limiting systemic drug exposure. Ideally, such a device would also have the capability to be utilized with current stent technology to limit late stage thrombosis as well as deliver multiple drug mixtures within a single interventional procedure to treat the major conditions found in stenosed vessels such as restenosis, thrombosis, and inflammation. Drugs such as Paclitaxel and Sirolimus are known to inhibit some of the processes that lead to restenosis, if cellular uptake occurs. Presence of a carrier molecule to promote cellular uptake is critical to increase clinical efficacy. We propose a product, InfusRX, that retains the benefits of interventional balloon devices and has the potential to expand clinical efficacy by controlling drug delivery and cellular uptake. The proposed device makes improvement in two areas: (1) the mechanical delivery of pharmacotherapeutics via a balloon- based deviced, and (2) the chemical formulation of drug carrier molecule to enhance the efficiency of drug transport into tissue.
The specific aims of this proposal are to assess the feasibility of the InfusRx device and drug formation of Paclitaxel and carrier molecule to treat vascular restenosis.

Public Health Relevance

The goal of this project is to assess the feasibility of a minimally invasive balloon-based drug infusion device and therapeutic agent to treat cardiovascular disease. The InfusRX device retains the benefits of conventional interventional therapies and has the potential to expand clinical efficacy by more accurately controlling drug delivery and cellular uptake. Controlled local release of drug to affected vessels will provide improvements in patient care, treatment, and reduction in the overall health care burden associated with the world's leading killer - cardiovascular disease.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-CVRS-B (10))
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Lee, Albert
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Medi-Solve, LLC
United States
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