A press release reports that clinical trial results of Xeltis pulmonary valve show promising functionality of the living valves, which is developed in patients as a result of its restorative implants. The data were presented at the International Conference of Tissue-Engineered Heart Valves (ICTEHV) as part of the 2020 Heart Valve Society scientific meeting.
According to the press release, the data showed good outcomes of Xeltis pulmonary valve at one-year follow-up in six USA paediatric patients and two-year follow-up in 12 paediatric patients enrolled in EU and Asian trial sites. Xeltis heart valves provide a home to the patient’s own cells to form new tissue that progressively develops within the implant and takes over its functionality, as part of the body’s natural healing process.
Eighteen children born with congenital heart defects requiring right ventricular outflow tract (RVOT) reconstruction or Ross procedure were implanted with a Xeltis pulmonary valve as part of two separate trials. Of these, 12 patients have been enrolled in EU and Asia as part of the Xplore-I trial and followed for two years so far. Six additional patients have been enrolled in US centres, as part of the Xplore-2 trial, with one-year follow-up completed to date.
The underlying mechanism behind the “homing” process of Xeltis devices, called endogenous tissue restoration (ETR), is currently being studied at research centres around the world. The results from a joined preclinical research project conducted by Xeltis with Eindhoven University of Technology TU/e on ETR have also been presented at ICTEHV.
Ger Bennink (Department of Cardiothoracic Surgery, University of Cologne, Germany), who presented the data at ICTEHV, says: “One and two years after implant, the patient’s own tissue has already taken over valve functionality following the homing process enabled by Xeltis valves, whilst the original polymer implant has started to dissolve. What we are seeing working in these patients today is a newly formed valve made of their own tissue, developed within their body”.
Xeltis CEO Eliane Schutte comments: ““The positive results seen in children to date compelled our investigators, our company and our investors to progress our pulmonary valve clinical trial programme towards approval. This is the world’s first large scale clinical trial of a fully novel heart valve designed to be naturally replaced by patients’ living, healthy tissue. Xeltis technology has the potential to overcome this burden and to offer better solutions for patients.”