AR Tzafriri, A-M Spognardi, JH Keating, MW Kayo, R Mandal. ‘Chronic Preclinical Safety And Efficacy Of The Supraflex Cruz Sirolimus Eluting Stent In The Swine Coronary Artery Model.’ Presented at: CRT 2026.
Background: We evaluated the preclinical safety of a coronary sirolimus eluting stent with an ultrathin strut and a bioresorbable polymer coating.
Methods: Stents coated with 1.4 μg/mm2 sirolimus (Supraflex Cruz Sirolimus Eluting Coronary Stent System, India) were implanted into swine coronary arteries on Day 0 (up to n=3/pig, balloon:artery=1.05-1.15:1). Angiography was performed on Day 0 (before, during and after device deployment) and pre-euthanasia for chronic groups to evaluate vascular response and TIMI flow. Animal health was monitored at regular intervals, including incision site and clinical observations, body weights/condition, and clinical pathology. Animals were euthanized at designated timepoints and subjected to a comprehensive necropsy. Hearts, representative tissue samples and stented vessels were collected for histopathological evaluation.
Results: Animals survived to their scheduled timepoint and did not exhibit clinical indications of overt disease, illness or adverse events, or findings that could be directly attributed to a complication resulting from the device or device implantation procedure. Angiography showed all vessels to be patent with normal blood flow (TIMI 3) at all time points. Quantitative angiography revealed mild neointimal responses across all time points, with average stenosis ranging from 6%±6% (at Day 910) to 17%±16% (at Day 365). Histologically there was progressive endothelialization of implanted vessels across time points, with minimal acute endothelial loss and complete coverage by Day 90. At all timepoints, luminal fibrin/thrombus was absent or nearly so. Neointima was minimal and mature at Day 30 and all subsequent timepoints. Histomorphometric analyses showed comparable arterial parameters across timepoints with nominal (14-25%) area stenosis, thin neointima, and broadly patent lumens. There were no histologic findings in downstream myocardium.
Conclusions: Overall, treatment in swine coronary arteries with the ultrathin strut Supraflex Cruz Sirolimus Eluting Coronary Stent System, which utilized a bioresorbable coating matrix to regulate release, resulted in mild neointimal responses across all time points, and no adverse safety events.
Presented at Cardiovascular Research Technologies (CRT), 2026 March 7-10, Washington DC.