Xeltis has started the first-ever pivotal trial for 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 Xplore2/Pivotal study. RVOT reconstruction is a procedure needed to correct certain congenital heart defects.
Following implantation, Xeltis’ synthetic restorative pulmonary heart valves 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 it 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, M.D., 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, which currently include: Cincinnati Children’s Hospital, Cincinnati (OH); University of Texas Southwestern Medical Center, Dallas (TX); Children’s Hospital Colorado, Aurora (CO); Children’s Hospital Los Angeles (CA); University Children’s Hospital, Krakow (Poland); National Cardiology Hospital Sofia (Bulgaria); National Heart Institute, Kuala Lumpur (Malaysia). For further information: www.xplore2MD.com; www.clinicaltrials.gov Identifier: NCT03022708. The implanted patients will be followed-up for five years.