A prospective, non-randomized, open label clinical study of a Restorative Pulmonary Heart Valve in Right Ventricular Outflow Tract (RVOT) reconstruction.

The Xplore-2 trial is actively enrolling patients. Please contact the enrolling trial centers for any enquiries.

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 Xplore-2 trial is actively enrolling patients.

Please contact the enrolling trial centers for any enquiries.

A RESTORATIVE PULMONARY VALVE

The options currently available for Right Ventricular Outflow Tract (RVOT) reconstruction, from homografts to mechanical and animal-derived pulmonary valves present some limitations:

  • They may have limited durability, in particular for young patients due to calcification and stenosis leading to repeated interventions
  • Or require life-long anticoagulation therapy, with potentially severe side effects
  • Or require a long wait, since donated homografts are in short supply

To address these limitations, the medical device company Xeltis developed a new generation of restorative heart valves to enable the body to restore new, living heart valves with patient’s own tissue. They have a highly porous micro-structure, designed to allow the patient’s tissue to infiltrate it and gradually restore a fully functional, living 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 enable a completely new treatment approach in heart valve therapy.

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Device Safety

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Low Re-Intervention

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Growth Potential

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Low Infection

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Availability

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Cost- Effective

ENDOGENOUS TISSUE RESTORATION (ETR)

IMPLANTATION

IMPLANTATION

The porous micro-structure allows patients cells to use it as a home to form new tissue
NEOTISSUE-photo: restorative pulmonary heart valve

NEOTISSUE FORMATION

As new tissue forms, it naturally turns Xeltis implant into a new, living heart valve.
FUNCTIONAL-photo: restorative pulmonary heart valve

FUNCTIONAL RESTORATION

As the new, living heart valve takes over functionality, the original implant gradually absorbs in the body

ETR IN ACTION

RESULTS TO DATE

To date 18 patients have been successfully implanted with Xeltis restorative pulmonary valves in the USA, Europe and Asia as part of the Xplore-1 and Xplore-2 trials.

Patients have been carefully followed up and evidence from more than 60 patient/years confirmed the positive safety profile of this novel technology.

Results from existing trials on Xeltis restorative technology have been published in peer-reviewed publications:

Xeltis’ bio-restorative heart valves are made of supramolecular polymers, based on Nobel prize awarded science.

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

FURTHER RESOURCES

Should you like to discuss the trial with your patients

You can suggest they visit www.xplore2trial.com