A prospective, non-randomized, open label clinical study of a Restorative Pulmonary Heart Valve in Right Ventricular Outflow Tract (RVOT) reconstruction.
The Xplore2/Pivotal trial is actively enrolling patients in centers in the United States, Europe and Asia.
XPLORE2/PIVOTAL IS A CLINICAL RESEARCH STUDY ON AN INVESTIGATIONAL DEVICE NOT APPROVED FOR USE OUTSIDE OF CLINICAL TRIALS IN THE US, EU AND ASIA.
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 Xplore2/Pivotal 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 sometimes 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.
ENDOGENOUS TISSUE RESTORATION (ETR)
The porous micro-structure allows patients cells to use the device as a home to form new tissue
As new tissue forms, it naturally turns Xeltis’ implant into a new, living heart valve
As the new, living heart valve takes over functionality, the original implant gradually absorbs in the body
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 First-In-Human and Xplore-2 FDA Early Feasibility studies.
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:
- Morales D et al. Restorative pulmonary valve, one and two-year results in patients. Frontiers in Cardiovascular Medicine
- Bennink G et al. Restorative pulmonary valve in preclinical studies. The Journal of Thoracic and Cardiovascular Surgery
- Jewell C. Synthetic valves in one-year animal studies. Science Translational Medicine
- Webber M et al. Supramolecular biomaterials. Nature Materials
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