Promising early outcomes from two clinical trials of Xeltis pulmonary valve confirm the excellent safety and performance of its bio-restorative RestoreXTM technology. Published in the peer-reviewed journal Frontiers, the data included results from the First-in-Human Xplore-1 trial conducted in 12 pediatric patients implanted in Europe and Asia, and from the Early Feasibility study ‘Xplore-2’ in six pediatric patients implanted in the USA.
All patients in both trials completed 12 months of follow-up and are clinically well (NYHA functional class I). Seventeen of the 18 conduits have shown no evidence of progressive stenosis, dilation or aneurysm formation and are free from device-related re-intervention one year after intervention. The Xplore-2 trial confirmed the positive performance and safety profile from Xplore-1 and showed improved results on valve functionality at 12 months follow-up.
“These results offer promising signs of the technology’s potential to change the treatment paradigm for children requiring Right Ventricular Outflow Tract (RVOT) reconstruction”, stated Professor David Morales, from Cincinnati Children’s Hospital Medical Center, Ohio (USA), one of the implanting clinicians. “I am especially encouraged by the Xplore-2 results, including the consistently low rate of re-operations and re-intervention,” he concluded.