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.

Please contact the relevant trial centers for any enquiries.

A RESTORATIVE PULMONARY VALVE

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)

IMPLANTATION

IMPLANTATION

NEOTISSUE-photo: restorative pulmonary heart valve

NEOTISSUE FORMATION

FUNCTIONAL-photo: restorative pulmonary heart valve

FUNCTIONAL RESTORATION

For full study information and details please visit:
http://www.clinicaltrials.gov Study Number NCT03022708.
To learn more about Xeltis, the study sponsor, please visit www.xeltis.com,
phone: +866 818 8461 or email: xplore2@xeltis.com

FURTHER RESOURCES

For more information to share with your patients about RVOT reconstruction, watch Mended Little Hearts’ webinar ‘A Future without Reoperations’ by Professor Bennink, University of Cologne (D):

Download the Mended Little Hearts webinar ‘A Future without Reoperations’ in PDF format here: