The initiation of the Xplore2 pivotal trial of synthetic restorative pulmonary heart valve has been announced by Xeltis, which has operations currently in the United States and the Netherlands and was formed by merging a Dutch and Swiss university spin-off.
Xeltis bioabsorbable pulmonary valved conduit
Restoration of the endogenous tissue is utilized by the electrospun polymer-made restorative cardiovascular devices developed by the company. The patient's tissue undergoes colonization to enable the evolution of the Xeltis device into a wholly functioning, natural heart valve. The patient's tissue populates the porous microstructure of the implant and gradually forms a functional new heart valve. The electrospun polymer used to make the synthetic device eventually gets resorbed into the body. As a part of the global study, successful implantation of this valve has been carried out in pediatric patients requiring right ventricular outflow tract (RVOT) reconstruction.
Xplore2 is an interventional trial to assess the safety and efficacy of Xeltis bioabsorbable pulmonary valved conduit. Dr. Morales, Director at the Congenital Heart Surgery, Cincinnati Children's Hospital, and Professor, Department of Pediatrics, is the principal global investigator of the trial.
About 50 patients undergoing right RVOT reconstruction are being evaluated for the feasibility of the restorative pulmonary valve in the nonrandomized, prospective, FDA-approved Xplore2 trial. 15 centers across Europe, Asia, and the United States are a part of the trial that will follow-up with patients for 5 years. The first patient of the Xplore2 trial was implanted by Professor Tomasz Mroczek, MD, a cardiothoracic surgeon at the Polish American Children's Hospital in Krakow, Poland.
Dr. Morales said that the physical and psychological burdens of repeated intervention could be reduced by a device with a longer lifespan and that grows with the patient. The quality of life of RVOT patients can, thus, be changed significantly by a regenerating heart valve. Promising results have been observed with Xeltis restorative pulmonary valve implanted in 18 patients as a part of other ongoing trials, added Prof. Mroczek.
Dr. Morales et al. published the early study data from the Xplore2 trial in the Frontiers in Cardiovascular Medicine.