In vivo distribution of particulate matter from coated angioplasty balloon catheters.

Most catheter-based vascular medical devices today have hydrophilic lubricious coatings. This study was designed to perform a territory-based downstream analysis of end organs subsequent to angioplasty with coated balloon catheters to better understand the potential in vivo physiological consequence of coating wear materials. Coronary angioplasty was performed on swine using balloon catheters modified with two polyvinylpyrrolidone (PVP)-based coatings of similar lubricity, but different levels of particulates (5-fold) when tested in a tortuous path model. Myocardial tissues examined 28 days post-angioplasty revealed no visible particulates in the animals treated with the lower particulate catheters while 3 of 40 sections from higher particulate catheters contained amorphous foreign material, and 1 of 40 sections from tissue treated with uncoated catheters had amorphous foreign material. Non-target organs and downstream muscle revealed no particulates for any of the treatments. Histological analysis showed that the overall number of vessels with embolic foreign material was low and evidence of myocyte necrosis was rare with either of the coatings investigated in this study.