Data from a two-year preclinical study on Xeltis’ pulmonary valve showed satisfactory functionality and good safety profile, including no stenosis and limited calcification. The results showed better safety profile compared to the pulmonary valved conduit used as control. The data have been presented today at the Heart Valve Society’s annual meeting in Monaco.
“With no device-related SAEs, good functionality and better safety profile compared to control, the in vivo results suggest that a restorative approach may be an effective future option in heart valve replacement,” said Doctor Gerardus Bennink, Head and Chief Pediatric Cardio-Thoracic Congenital Surgery, Heart Center of the University of Cologne (Germany) and one of the study authors.
“These data supported the initiation of the clinical feasibility trial for Xeltis’ pulmonary valve in EU and Asia,” commented Doctor Zsolt Prodan, Head of Congenital Heart Surgery at Paediatric Cardiac Centre in Budapest, who performed the first clinical trial intervention. “We anticipate reporting on the 3-month follow-up soon; the safety results so far are very encouraging.”
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