Effects of external crushing forces on a novel below-the-knee vascular implant.

Abstract

The Tack Endovascular System® is a novel vascular implant designed to focally treat dissections with low radial force and minimal metal burden. As there are currently no approved below-the-knee (BTK) implants in the USA, a unique, 3-stage model was developed to characterize crush deformation and fracture potential of the Tack Endovascular System in BTK arteries. First, 35 Tack® implants were deployed bilaterally in the posterior tibial, anterior tibial, and peroneal arteries of 3 cadavers, and clinically relevant external forces were applied to simulate BTK crushing deformation including focal load, leg crossing, and leg bending. Intravascular ultrasound images of the implanted vessels were used to assess the magnitude of artery deformation. Outputs of the cadaver testing were input into a finite element analysis (FEA) model to determine the appropriate conditions for subsequent bench testing. Tack implants were then subjected to increasing crush forces at 30Hz for up to 650,000 cycles at 25% flat plate deformation within the worst-case FEA test condition. Crush deformation across all arteries ranged from 0% to 23.1%. The posterior tibial artery and large male cadaver exhibited the most vulnerability to external crush forces, while the small female model exhibited the most resistance. No fractures were observed during cadaver or bench testing. This study characterized deformation forces in tibial arteries during various loading conditions. Tack implants withstood the loading conditions without fracture within the limits of this ex-vivo human vascular model and in-vitro bench testing.