Xeltis, producers of clinical-stage medical devices, has successfully completed three implants of the first heart valve that supports cardiovascular restoration in three pediatric patients.
The endogenous tissue restoration method to cardiovascular regeneration uses the patient’s own tissue to restore complex cardiac systems. The bioabsorbable heart valve uses the body's natural healing process to restore cardiovascular structures through its porous construction. As the restoration of the cardiac valves or vessels becomes fully functional of the body’s own tissue, the implant is then absorbed into the body.
The Xplore-I clinical trial tested the Xeltis bioabsorbable pulmonary heart valve on patients from 2 to 21 years old. The trail examined the survival rates of patients six months after a Right Ventricular Outflow Tract (RVOT) reconstruction and the success of the bio absorbable heart valve.
Normally given to children born with congenital heart defects, RVOT involves open-heart surgery and a pulmonary heart valve replacement. Patients in the trial have been discharged and the bioabsorbale implant is working according to plan, according to Zsolt Prodan, MD, Head of Congenital Heart Surgery at Paediatric Cardiac Centre in Budapest, Hungary, who performed the first two interventions
"Reconstruction and replacement of diseased heart valves in children using patients' own tissue could help reduce the risk of complications and of re-interventions observed with animal and human donor implants," said Thierry Carrel, MD, principal investigator of the initial study, and Professor of Surgery at the Clinic for Cardiovascular Surgery at the University Hospital Bern. "We are quite confident regarding this technology, since children from the precursor feasibility study on bio-absorbable blood vessels demonstrate excellent results over two years after implantation.”