European medtech Xeltis announced that its restorative heart valve, the world’s first, has been implanted in three children participating in a clinical trial.
The bioabsorbable pulmonary heart valve has a Humanitarian Use Designation for the correction or reconstruction of the right ventricular outflow tract (RVOT) in children. RVOT reconstruction is an open-heart procedure that usually involves pulmonary heart valve replacement and is typically performed in children with congenital heart defects.
Once implanted, the porous valve leverages the body’s natural healing process, encouraging healthy tissue to spread through it. As the new, healthy tissue grows, it forms a new heart valve or blood vessel around the structure of the implant, the company said in a statement. Eventually, the new tissue takes over the function of the implant, which gets absorbed into the body.
The Xplore-I study is a multicenter feasibility trial currently enrolling patients aged 2 to 21 in Europe. The study’s goal is to evaluate the 6-month survival rate of patients undergoing RVOT replacement using the bioabsorbable valve. The first three patients received the implant in Hungary and Poland.
"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 principal investigator Dr. Thierry Carrel, a professor of surgery at University Hospital Bern’s Clinic for Cardiovascular Surgery in Switzerland, in the statement.
Xeltis reeled in $34 million in Series B funding in 2014 to get the bioabsorbable valve to market. While its first target, congenital heart defects, is a specific orphan market, it has bigger plans. With its tech, dubbed Endogenous Tissue Growth, the company hopes to change the way cardiac and vascular surgery are performed.