The Children’s Hospital Colorado has joined other prominent U.S. pediatric centers in the Xplore-2 clinical research study, the first medical center in the Mountain States to take part in the trial.
The medical institutions already enrolling patients as part of the Xplore-2 trial include: Boston Children’s Hospital, Children’s Healthcare of Atlanta, Children’s Hospital Los Angeles, Children’s Hospital of Philadelphia, Children’s Hospital of Pittsburgh of UPMC, Cincinnati Children’s Hospital and New York Presbyterian/Columbia University Medical Center.
Xplore-2 is an FDA-approved Early Feasibility Study evaluating Xeltis’ novel restorative pulmonary heart valve for Right Ventricular Outflow Tract (RVOT) reconstruction. Xeltis’ restorative pulmonary valve is an investigational device not approved for use in the United States.
Every year in the USA, approximately 40,000 children are born with congenital heart disease (CHD). Around 15-20 percent of these children have congenital defects of the RVOT. Defective RVOTs require surgical intervention, which often involves replacement of the pulmonary valve.