One-year follow-up results from pediatric feasibility study of Xeltis bioabsorbable cardiovascular pulmonary graft have been presented as a late-breaker at the 96th American Association of Thoracic Surgery (AATS) annual meeting today.
All five children, aged 4 to 12 years at study enrollment, had only one functioning heart ventricle as a result of congenital heart defects and showed significant improvement in their general conditions one year after surgery. The 12-month data also showed anatomical and functional stability of the graft and no device-related adverse events.
The success of this feasibility trial paved the way for Xeltis to develop a bioabsorbable pulmonary heart valve, which will enter clinical trials in Europe in 2016.
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