Xeltis Initiates Xplore2 Pivotal Trial of Its Synthetic Restorative Pulmonary Heart Valve

July 8, 2021 – Xeltis announced that it has started the Xplore2 pivotal trial for its synthetic restorative bioresorbable pulmonary valve. To date, pediatric patients requiring right ventricular outflow tract (RVOT) reconstruction have been successfully implanted as part of the global study.

From Xeltis' polymer-based platform, the company is developing restorative cardiovascular devices that use endogenous tissue restoration. Xeltis, which was formed through the merger of a Dutch and a Swiss university spin-off, currently has operations in the Netherlands and in the United States.

The company explained that after implantation, the Xeltis device evolves into a fully functioning, natural heart valve through colonization by the patient’s own tissue. The implants’ porous microstructure enables the patient’s own tissue to populate it and naturally form a new heart valve that takes over functionality over time. The original synthetic structure, made from electrospun polymers, resorbs into the body.

According to the company, Xplore2 is a prospective, nonrandomized clinical study to assess safety and efficacy of the restorative pulmonary valve in up to 50 patients undergoing RVOT reconstruction. Conducted through an FDA-approved investigational device exemption, the trial will be conducted at up to 15 centers in the United States, Europe, and Asia. The implanted patients will be followed-up for 5 years.

David Morales, MD, serves as global principal investigator of the trial. Dr. Morales is Director, Congenital Heart Surgery, Cincinnati Children’s Hospital and Professor, Department of Pediatrics at University of Cincinnati in Cincinnati, Ohio.

Professor Tomasz Mroczek, MD, cardiothoracic surgeon at the Polish American Children's Hospital in Krakow, Poland, implanted the first patient of the Xplore2 pivotal trial. He also previously implanted three pediatric patients as part of the ongoing Xplore-1 study for the Xeltis pulmonary valve.

"Regenerating living heart valves in patients requiring RVOT reconstruction may substantially change their quality of life," commented Dr. Morales in the Xeltis press release. "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."

"Data from 18 patients implanted with the Xeltis restorative pulmonary valve as part of other ongoing clinical trials are very promising," commented Prof. Mroczek in the company press release. "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."

Xeltis advised that in March 2021, the 2-year results from the Xplore-1 trial conducted in 12 patients in Europe and Asia and the 1-year data from the Xplore-2 early feasibility study in six patients were published by Dr. Morales et al in the Frontiers in Cardiovascular Medicine.

Further outcomes from patients up to 4 years postsurgery confirm consistently low repeat reintervention rates and offer promising signs of the technology’s superior potential, stated Xeltis.