DESolve I FIM: Evaluation of a FIM trial results of a bioabsorbable stent (15 patients).

This trial is a prospective evaluation of DESolveTM bioabsorbable coronary stent implantation in a 15 patient cohort enrolled in New Zealand and Belgium. At 6 months follow up, late lumen loss was 0,19 mm, binary restenosis was 0% and thrombosis was absent. OCT evaluation showed excellent stent apposition, and 98% of evaluated struts were covered with a thin neointimal layer. Neointimal obstruction percentage was 7,1%.

According to Dr. Verheye, preclinical evaluation showed excellent results with a low percentage of acute recoil or scaffold shrinkage (6%), which shows great radial strength. This stent is reabsorbed in 1-2 years. This device is available in a broad range of sizes and has some features that make them particularly interesting, such as their capacity to limit malapposition and their resistance to fracture. Preliminary clinical outcomes suggest a promising future due to its potent antiproliferative effect and its adequate reendothelization. In view of these results, the DESolveTM Nx Pivotal Trial (n=120) has started enrolling in Europe, New Zealand and Brazil.