Xplore-2 Pivotal is an FDA-approved clinical research study on a novel, restorative pulmonary heart valve
The Xplore-2 Pivotal study aims to demonstrate the clinical safety and efficacy of the Xeltis restorative pulmonary heart valve device in patients requiring Right Ventricular Outflow Tract (RVOT) reconstruction due to congenital heart defects (CHD).
WHY DO WE NEED A NEW PULMONARY HEART VALVE?
Every year in the USA, approximately 40,000 children are born with congenital heart disease (CHD). Approximately 15-20 percent of these children have congenital defects of the Right Ventricular Outflow Tract (RVOT) that disrupt blood flow to the pulmonary arteries. Defective RVOTs require a surgical intervention called RVOT reconstruction, which often involves replacement of the pulmonary valve.
- Calcification of the valve: build-up of minerals, leading to stiff leaflets
- Stenosis of the valve: tissue formation on the valve, leading to its narrowing.
Both situations reduce blood flow.
As a result, many currently available options for pulmonary valve replacements will need to be replaced as the child grows, and often more than one additional valve replacement will be required.
Watch Professor Bennink, University of Cologne (D), explaining more about RVOT reconstruction here:
A novel, restorative pulmonary valve
To address these limitations, a novel generation of restorative heart valves have been developed and are currently under clinical investigation.
They are designed to enable the body to naturally restore a new heart valve with patient's own tissue through a novel therapeutic approach called Endogenous Tissue Restoration (ETR).
The ETR approach concept is based on the fact that a patient's healing system naturally develops tissue that can fill the porous structure of the restorative valve, forming a novel and fully functional valve within it. As ETR occurs, the restorative implants are designed to gradually absorb in the body.
PLEASE NOTE: XELTIS CANNOT PROVIDE ANY INFORMATION TO INDIVIDUAL PATIENTS IN RELATIONS TO CLINICAL TRIALS, DUE TO PRIVACY AND CLINICAL PRACTICE REGULATIONS; PLEASE CONTACT THE RELEVANT TRIAL CENTERS FOR ANY ENQUIRIES
Xplore-2 Research Centers
Children's Healthcare of Atlanta
Boston Children's Hospital
Children's Hospital Colorado
Cincinnati Children’s Hospital Medical Center
Children’s Hospital Los Angeles
New York Presbyterian Hospital - Columbia University
New York, 10032
Children’s Hospital of Philadelphia
Research Institute, Philadelphia,
Children’s Hospital of Pittsburgh of UPMC
4401 Penn Avenue, Pittsburgh,