Device profile of the Inspiris Resilia valve for aortic valve replacement: overview of its safety and efficacy.

INTRODUCTION The Inspiris Resilia tissue valve was recently introduced into clinical practice. This review summarizes the pre-clinical and clinical studies leading to this new bioprosthesis. AREAS COVERED The novel Resilia tissue was tested extensively in a large animal model. The clinical use of the tissue started in 2011 with the European Feasibility study, followed by a North-American multi-center study. Since 2017, the Inspiris Resilia valve has been in full commercial use. Further prospective evaluations and registries are ongoing. EXPERT OPINION The Inspiris Resilia valve was clinically introduced after pre-clinical tests revealed superiority compared to contemporary therapy such as the Perimount valve. Prospective long-term follow-up studies on Resilia are ongoing since 2011 and reveal no major complications. Full 5-year data show no signs of early degeneration, but longer follow-up is certainly still needed. Several prospective registries are actively monitoring the outcome with the Inspiris Resilia valve now. The novel tissue, designed to mitigate calcification and increase durability, together with the expandable stent, facilitating potential future valve-in-valve (ViV) procedures, are the cutting-edge aspects. Clinical use in younger patients is currently ongoing: their follow-up and outcome will determine the added value of this valve.