Date of Award
Director of Thesis
Peripheral artery disease (PAD), the narrowing of peripheral arteries located in areas such as the arms and legs, is a common disease that affects 12% to 20% of people over 65. Numerous therapies have been developed to treat PAD, the most recent technology being drug-coated balloons. Drug-coated balloons release drugs, such as Paclitaxel (PTX), into the arterial wall during balloon angioplasty to locally treat PAD. Current levels of drug transfer from the balloon to the vascular endothelium are at a low 10%-18%. Our Biomedical Engineering Senior Design project aims to increase drug delivery of drug-coated balloons by manipulating the clinically-controllable variables of drug+excipient formulation, balloon inflation pressure, and balloon inflation time. To study the effects of these variable on drug transfer, we first developed in vitro models of the drug-coated balloon (PTX+Urea and PTX+Shellac formulations) and vascular endothelium (porcine blood vessels). These models were then subjected to uniaxial compression testing to simulate balloon inflation against the vessel wall at set inflation pressures and times. Our study found drug transfer to increase with increasing inflation pressure in the PTX+Urea formulation. In contrast, drug transfer for the PTX+Shellac formulation increased with inflation time. Though we were unable to increase drug transfer past 17%, our study indicates that manipulating the above clinical variables can be a powerful tool towards increasing efficacy of drug-coated balloons.
Galan, Alexander; Bidinger, Eric; Godoy, Franco; and Patel, Shrusti, "Increasing Drug Delivery Efficacy of Drug-Coated Balloons" (2018). Senior Theses. 256.