At the American Association for Thoracic Surgery Annual Meeting this week, surgeons from the Bakoulev Center for Cardiovascular Surgery, Moscow are reporting on the successful implantation of bioabsorbable cardiac pulmonary valves in children undergoing reconstructive heart surgery. The devices are made by Xeltis, a Swiss firm, out of electrospun bioabsorbable polymers. These polymers allow for collagen and blood vessels to form within the material, the tissue taking over as the implant is absorbed and flushed by the body.
In the study, five children between four and 12 years old with single-ventricle congenital malformations underwent the common extracardiac Fontan procedure, receiving the device that linked the inferior vena cava with the right pulmonary artery.
No device related adverse events were reported and a year following the procedure the kids were doing quite well.
The Xeltis bioabsorbable cardiac pulmonary valve just received FDA’s Humanitarian Use Device designation in March of this year.