A prospective, non-randomized, open label clinical study of a Restorative Pulmonary Heart Valve in Right Ventricular Outflow Tract (RVOT) reconstruction.
XPLORE-2 IS A CLINICAL RESEARCH STUDY ON AN INVESTIGATIONAL DEVICE NOT APPROVED FOR USE IN THE USA.
PLEASE NOTE: XELTIS CANNOT PROVIDE ANY INFORMATION TO INDIVIDUAL PATIENTS AND THEIR CLINICIANS IN RELATIONS TO CLINICAL TRIALS, DUE TO PRIVACY AND CLINICAL PRACTICE REGULATIONS.
The first enrollment phase of the Xplore-2 trial is now complete and follow-up activities are underway.
The options currently available for RVOT reconstruction, from homografts to mechanical and animal-derived pulmonary valves, may either have limited durability leading to repeated interventions, or require life-long anticoagulation therapy, with potentially severe side effects.
To address these limitations, a new generation of restorative heart valves made of polymers have been developed by European company Xeltis.
They have a highly porous structure, designed to allow the patient’s own tissue to infiltrate it, to gradually restore a fully functional valve; this process is called Endogenous Tissue Restoration (ETR).
Such implants have a potential to reduce post-operative device-related complications and to adapt to the overall body growth.
They may therefore represent a completely new approach in heart valve therapy.
ENDOGENOUS TISSUE RESTORATION (ETR)