Preliminary Xplore-1 data show promise at ECHSA
Preliminary one-year data from the Xplore-1 clinical trial have shown that Xeltis’ restorative pulmonary heart valve has potential for use in RVOT reconstruction.
In a presentation at the ECHSA meeting in Cascais, Portugal, trial investigator Professor Tomasz Mroczek from the Children’s University Hospital, Krakow, Poland, illustrated preliminary one-year data from the Xplore-1 trial. Xplore-1 was conducted in three trial centers in the European Union and in Asia, and it included 12 pediatric patients.
Professor Mroczek illustrated the experience with the procedure and reported that all patients, including the three he implanted in Krakow, have successfully recovered and completed their one-year follow up, with no device-related complications or re-operations
“The early outcomes from the Xplore-1 trial experience suggest that Xeltis’ technology has the potential to be used for RVOT reconstruction in clinical practice,” Prof. Mrozeck concluded.
Xplore-1 is the first clinical trial evaluating Xeltis’ restorative heart valves. A number of academic research teams in Europe and in the United States are investigating the fundamental science behind Endogenous Tissue Restoration in heart valves. Xeltis’ pulmonary valve is the first of its kind to reach clinical trial stage.
A second clinical trial on Xeltis’ pulmonary valve, the FDA-approved Xplore-2 study, is currently under way in six medical centers in the USA.