Angiographic Safety and Efficacy of the ReSolv Flow-Diverting Stent in a Rabbit Model.

Abstract

Bioresorbable polymer-based flow-diverting stents have potential benefits over existing metal devices. This study aimed to evaluate the safety and efficacy of the novel ReSolv device, which is a primarily polymer-based flow-diverting stent, using the in vivo rabbit sidewall saccular aneurysm model. ReSolv stents were deployed in 14 New Zealand White rabbits that had undergone aneurysm creation procedures. Animals were allocated to follow-up time points of 1, 3, 6, 9, 12, 16, or 18 months. Angiographic images were evaluated by an independent neurointerventionalist blinded to follow-up time points for (1) in-stent stenosis, (2) parent vessel and jailed side branch patency, (3) wall apposition, and (4) aneurysm occlusion using the Raymond-Roy Occlusion Classification (RROC), O'Kelly Marotta grading scale, and the 4F flow diversion predictive score. Primary efficacy outcome was defined as RROC Class I or II. At a median follow-up time of 7.5 months, parent vessel (14/14) and jailed side (33/33) branches were patent in all cases. There was no development of thrombus on the stent or cases of significant in-stent stenosis, and all stents had good wall apposition. Adequate occlusion was found in 85.7% (n = 12) of animals, including an RROC Class I in 64.3% (n = 9) and RROC Class II in 21.4% (n = 3). The ReSolv stent shows encouraging angiographic safety and efficacy outcomes after placement in a rabbit sidewall saccular aneurysm model. Longer term studies are ongoing to determine eventual fate of the aneurysm, parent vessel, and jailed side branches after absorption of the polymer component of the stent.