Xplore-2 is an FDA-approved clinical research study on a novel, restorative Pulmonary Heart Valve: a device used to help improve blood flow from the heart to the lungs.

Xplore-2 is a clinical research study on an investigational device
not approved for use in the USA.


The first enrollment phase of the Xplore-2 trial is now complete
and follow-up activities are underway

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.

Pulmonary valve replacements are generally either made from animal tissue (biological valves), or from artificial materials (mechanical valves), or come from human donors (homografts). They are life-savers for patients with RVOT abnormalities. Artificial heart valves work but there are limitations associated with them – the most common are:
  • 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

Atlanta

Children's Healthcare of Atlanta
Atlanta,
Georgia, 30322

Boston

Boston Children's Hospital
Boston,
Massachusetts, 02115

Denver

Children's Hospital Colorado
Aurora, Denver,
Colorado, 80045

Cincinnati

Cincinnati Children’s Hospital Medical Center
Cincinnati,
Ohio, 45229


Los Angeles

Children’s Hospital Los Angeles
Los Angeles,
California, 90027

New York

New York Presbyterian Hospital - Columbia University
New York,
New York, 10032

Philadelphia

Children’s Hospital of Philadelphia
Research Institute, Philadelphia,
Pennsylvania, 19104

Pittsburgh

Children’s Hospital of Pittsburgh of UPMC
4401 Penn Avenue, Pittsburgh,
Pennsylvania, 15224

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