Children's Hospital Colorado today announced it has joined the Xplore2/Pivotal trial, and is actively enrolling patients for the first-ever pivotal trial of a synthetic restorative pulmonary valve. To date, pediatric patients requiring right ventricular outflow tract (RVOT) reconstruction have been successfully implanted as part of the global, FDA-approved study. RVOT reconstruction is a procedure needed to correct certain congenital heart defects.
Following implantation, the synthetic restorative pulmonary heart valves - developed by medtech company Xeltis - evolve into fully functioning, natural heart valves through colonization by the patient's own tissue. The implants' porous micro-structure enables the patient's own tissue to populate the device and naturally form a new heart valve that takes over functionality over time. Meanwhile, the original synthetic structure, made from electrospun polymers, resorbs into the body.
"Regenerating living heart valves in patients requiring RVOT reconstruction may substantially change their quality of life," said David Morales, MD, director, Congenital Heart Surgery, Cincinnati Children's Hospital and Professor, Department of Pediatrics at University of Cincinnati, who is global principal investigator of the trial. "A device that has longer life-span and that potentially grows with the patient would reduce repeated interventions and the physical and psychological burden associated to them."
Xplore2/Pivotal is a prospective, non-randomized clinical study to assess safety and efficacy of the restorative pulmonary valve in up to 50 patients undergoing RVOT reconstruction. The U.S. FDA-approved Investigational Device Exemption trial will be conducted in up to 15 centers in the U.S., Europe and Asia. The implanted patients will be followed-up for five years.
Data from the 18 patients implanted with the Xeltis restorative pulmonary valve as part of other ongoing clinical trials is promising and the positive safety profile and performance seen in over 60 patient-years of follow-up provide strong indication of a potential best-in-class device to reduce re-operations and improve lives for patients. There has been no ideal solution for these patients. It is excting that Children's Hospital Colorado has been invited to participate in a clinical trial that may lead to an ideal valve solution for children who need a pulmonary valve replacement."
Max Mitchell, MD, cardiothoracic surgeon and co-director of the Extracorporeal Membrane Oxygenation Program at Children's Hospital Colorado
The two-year results from the ongoing Xplore-1 trial conducted in 12 patients in Europe and Asia and the one-year data from the U.S. FDA-approved Early Feasibility Study (EFS) Xplore-2 in six patients have been recently published in the peer-reviewed journal Frontiers in Cardiovascular Medicine. Further outcomes from patients up to four years post-surgery confirm consistently low repeat re-intervention rates and offer promising signs of the technology's superior potential.
"The Xeltis pulmonary heart valve is the most advanced heart valve with regenerative properties based only on a biocompatible synthetic structure and the first ever synthetic restorative valve to enter a pivotal trial," said Eliane Schutte, Xeltis CEO. "We are extremely proud of our clinical program progression, which also includes two small diameter blood vessel applications. All our regenerative devices promise to offer solutions that overcome the limitations of existing technologies – or the complete lack of them."
In addition to its restorative pulmonary valve, Xeltis has developed the first-ever restorative synthetic coronary artery bypass graft (CABG) to have shown successful long-term results in long preclinical trials and the first-ever restorative synthetic vascular access graft for patients that need dialysis.