First-Ever Pivotal Trial of Synthetic Restorative Pulmonary Heart Valve

xeltis valve for RVOT reconstruction

Based in Eindhoven, Netherlands, Xeltis is a clinical-stage developer of advanced polymer-based restorative cardiovascular devices. The company has now announced the start of the first-ever pivotal trial for a synthetic restorative pulmonary valve.


Search our pages for pulmonary heart valves and the cupboard is bare. That’s changed today with news of an exciting development in pediatric cardiac restorative surgery.

Right ventricular outflow tract (RVOT) reconstruction is a procedure to correct certain congenital heart defects. 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 (see images below). Made from electrospun polymers, the original synthetic structure resorbs into the body. These characteristics render the technology particularly appropriate for pediatric use.

Xeltis synthetic pulmonary heart valve becomes populated by patient's own tissue
Xeltis pulmonary heart valve, polymers resorb into the body over time

Xeltis developed the first-ever restorative synthetic coronary artery bypass graft (CABG) to have shown successful long-term results in long preclinical trials. It’s also responsible for the first-ever restorative synthetic vascular access graft for patients that need dialysis.

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.

With enrolment now commenced, pediatric patients requiring RVOT reconstruction have now been successfully implanted.

The two-year results from the Xplore-1 trial, already 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.

Investigator comments 

“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, 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.” 

Professor Tomasz Mroczek, cardio-thoracic surgeon at the Polish-American Children’s Hospital in Krakow, Poland performed the first patient implant in the study. He says, “Data from 18 patients implanted with the Xeltis restorative pulmonary valve as part of other ongoing clinical trials are very promising.

“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.” 

Company comments

“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.”

Share your thoughts

Your email address will not be published. Required fields are marked *