The Xplore-2 feasibility study under way in the US
The U.S. early feasibility study for the Xeltis’ restorative pulmonary valve is actively recruiting eligible patients. The Xplore-2 study will enroll 10 patients at four leading US pediatric centers.
Xeltis’ restorative pulmonary heart valves enable the patient’s body to form a new valve with its own tissue, potentially reducing the risk of further interventions.
For more information on study and the participating study centers, please visit the Xplore-2 website.
Every year in the US, approximately 40,000 children are born with congenital heart defects. About 15-20 percent of these patients will require surgical intervention for the reconstruction of their Right Ventricular Outflow Tract (RVOT), which includes replacement of the pulmonary valve.
Existing options for replacement of the pulmonary valve are made of animal tissue, artificial material or from human cadaveric donors are reported to have limited durability and often require life-long medical therapy.