Positive Xeltis data from two clinical trials on Endogenous Tissue Restoration (ETR) applications show encouraging progression for the RestoreX technology. The data have been shared at the 7th World Congress of Pediatric Cardiology & Cardiac Surgery (WCPCCS) in Barcelona, Spain.
Clinical data at up to 31 months following implantation of a restorative cardiovascular graft in five pediatric patients demonstrated positive anatomical and functional stability and no device-related adverse events in all patients. The second data set from the feasibility clinical trial of Xeltis’ pulmonary heart valve showed no device-related complications in 12 patients that had completed 6 weeks to 6 months follow-ups.
“At 31 months, the Xeltis implant is substantially absorbed by the body and functionality taken over by the new tissue formed through ETR,” explained Martijn Cox, Xeltis CTO and Co-Founder. “Consistently positive functionality at this stage begins to confirm the long-term potential of our restorative approach,” he added.
WCPCCS takes place on July 16-21, 2017, in the Centre Convencions Internacional de Barcelona (CCIB), Barcelona, Spain. WCPCCS intends to share latest innovations and data results of procedures with all professionals involved in the care of children’s heart disease and congenital heart disease of all ages.