Preliminary testing and evaluation of the renata minima stent, an infant stent capable of achieving adult dimensions

OBJECTIVES: This study sought to obtain in vivo data on a new stent and delivery system specifically designed for implantation in infants with the ability to be enlarged to adult dimensions. BACKGROUND: There are no endovascular stents designed for or approved for use in infants, nor is there a stent capable of being implanted at infant vessel diameters and achieving adult size while maintaining structural integrity. The Minima stent was designed to address these needs. METHODS: This study was performed in 6 piglets who underwent implantation of 22 Minima stents into the following locations: aorta (n = 11), branch pulmonary arteries (n = 6), and central veins (n = 5). RESULTS: Successful deployment occurred in 21/22 attempts. Two instances of post‐deployment migration occurred. Stents were re‐expanded at 1, 2, 3 and 5 months after implant. All stents regardless of location could be re‐dilated to the intended diameter to keep pace with somatic growth (implant diameter 6.9 +/− 1.2 mm; final diameter 16.1 mm +/− 1.4 mm). Histopathology at 1 and 5 months demonstrated widely patent vessel lumens with stent apposition to vessel wall, early mild inflammatory response surrounding stent struts, typical vascular damage and healing response to acute dilation and a progressive smooth neointimal growth covering stent struts over time. CONCLUSIONS: In this in vivo study of the Minima stent, there was high implant success, predictable re‐dilatability to adult diameters and favorable histopathology. Further study is warranted.