Positive data on the performance of Xeltis’ restorative pulmonary valve (PV) have been published in the peer-reviewed Journal of Thoracic and Cardiovascular Surgery (JTCVS). The data showed comparable performance results for Xeltis’ PV and the Hancock conduit, which is one of the current available options for patients who need a pulmonary heart valve replacement.
The encouraging results assessed the safety and functionality of Xeltis’ PV at 2, 6, and 12-months. Xeltis’ PV did not show any significant narrowing up to 12 months, with a peak of neo-intimal thickness at 6-months and ongoing degradation process from 2-month onwards. In comparison, the wall of the Hancock conduit showed more neo-intimal thickening, narrowing and calcification.
“Xeltis’ novel pulmonary valve results are encouraging,” explained Professor Virmani, President of CVPath Institute and co-author of the paper. “A performance comparable to existing devices, with potential for lower calcification and subsequent better longevity of the valve”, she added, “suggest the restorative approach may offer an improvement over current conduits available for children with complex congenital heart disease.”
These data further support the potential of Xeltis’ pulmonary valve following the recent publication of data showing positive hemodynamic performance of the valve in preclinical trials in peer-reviewed journal EuroIntervention.