Abraham R.Tzafriri, AnnaMariaSpognardi, LynnBailey, JohnKeating, PeterMarkham, GaryBinyamin, MariaPizarro, EitanKonstantino, Elazer R.Edelman. ‘Six Month Safety Evaluation Of The Chocolate Touch™ Drug-coated Balloon Catheter In The Swine Peripheral Artery Model.’ Presented at: CRT 2020, Feb 22-25; National Harbor, MD.
Summary: We evaluated the preclinical safety of a novel paclitaxel-coated balloon catheter (PCB) with a nitinol constraining structure positioned over it, designed to improve acute treatment of stenotic and occluded arteries. PCBs (TriReme Medical, Singapore) with 5.53mg PTX and (3μg/mm2, 6×80 mm) and a proprietary excipient were inflated for 120 sec in peripheral arteries of 34 Yorkshire swine (target balloon-to-artery ratio between 1.06:1-1.08:1). Treated arteries (n=48) received a single PCB inflation (clinical dose) or a 3 sequential PCB inflations at the same angiographic site.
All treatments with DCB and POBA were successful in peripheral vessels, with minimal or no adherent thrombus on removed catheters and survival of all animals to scheduled time points. Histologically, DCB treatments were associated with favorable tissue responses at both doses, consistent with device biocompatibility comparable to that observed with POBA. Arterial injury was rare and negligible, while inflammation was overall negligible to minimal. DCB treatments resulted in vascular changes, which were interpreted to predominantly reflect concomitant tissue responses related to both balloon deployment and presence of PTX, with no distinct excipient-related effects and no evidence of downstream or systemic adverse effects. Endothelialization was mostly complete in all groups, and neointima was minimal. Macroscopic, histologic and SEM findings indicated arterial patency and lack of thrombogenicity in both groups.
Conclusions: Overall, treatment in peripheral arteries with the Trireme DCB at 1x clinical dose or 3x safety margin dose resulted in acceptable acute device performance and no adverse safety events, and was similar to POBA.