LOCALIZED DRUG-DELIVERY IN ATHEROSCLEROTIC ARTERIES VIA A NEW BALLOON ANGIOPLASTY CATHETER WITH INTRAMURAL CHANNELS FOR SIMULTANEOUS LOCAL-DRUG DELIVERY

A dual-purpose angioplasty catheter with intramural channels and exterior pores for local drug delivery (''channeled balloon'') was studied in eight atherosclerotic human necropsy arteries and in 22 rabbits with atherosclerotic peripheral arteries, in which markers (0.005 mum to 15 mum) were infused locally at 2 atmospheres during simultaneous angioplasty of 6 atmospheres. Thirteen of the rabbits were sacrificed at 4 or 24 h after procedure to determine the intramural retention over time. Histology confirmed effective angioplasty and revealed presence of markers in the arterial wall in 29 of 43 treated arteries (67%), whereas all control segments without local delivery had no marker staining. Majority of the ineffective local delivery (12/14) occurred when 15 mum particles were infused (12/13 arteries without intramural markers), especially when examined 4 or 24 h later. Thus, in atherosclerotic arteries, the channeled balloon enabled simultaneous local drug delivery at low pressure during effective angioplasty, although particle size may play a role in successful intramural impregnation and retention. (C) 1995 Wiley-Liss, Inc.