Xeltis has announced that it has started a pivotal trial for a synthetic restorative pulmonary valve, which features porous micro-structure enabling the patient’s own tissue to populate it and naturally form a new heart valve.
To date, paediatric patients requiring right ventricular outflow tract (RVOT) reconstruction have been successfully implanted as part of the global, US Food and Drug Administration (FDA)-approved Xplore2/Pivotal study. RVOT reconstruction is a procedure needed to correct certain congenital heart defects.
In a press release, Xeltis detailed that following implantation, its synthetic restorative pulmonary heart valves evolve into fully functioning, natural heart valves through colonisation by the patient’s own tissue. The implants’ porous micro-structure enables the patient’s own tissue to populate it and form a new heart valve that takes over functionality over time. 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, director, Congenital Heart Surgery, Cincinnati Children’s Hospital and Professor, Department of Pediatrics at University of Cincinnati, Cincinnati, USA, who is global principal investigator of the trial. “A device that has longer lifespan 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-randomised clinical study to assess safety and efficacy of the restorative pulmonary valve in up to 50 patients undergoing RVOT reconstruction. The FDA-approved Investigational Device Exemption trial will be conducted in up to 15 centres in the USA, Europe and Asia. The implanted patients will be followed-up for five years.
“Data from 18 patients implanted with the Xeltis restorative pulmonary valve as part of other ongoing clinical trials are very promising,” said Professor Tomasz Mroczek, cardiothoracic surgeon at the Polish-American Children’s Hospital, Krakow, Poland. Mroczek implanted the first patient of the Xplore2/Pivotal trial and had also previously implanted three paediatric patients as part of the ongoing Xplore-1 study for the Xeltis pulmonary valve. “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.”
The two-year results from the Xplore-1 trial conducted in 12 patients in Europe and Asia and the one-year data from the US 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, Xeltis said.
“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 a 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.