One-year data from preclinical trials of Xeltis restorative coronary artery bypass graft (XABG) show that the device remained open to allow blood flow for 12 months in a challenging ovine model. The results were presented by Mohammed El-Kurdi, Xeltis’ vice president for R&D Vascular, at the International Society for Applied Cardiovascular Biology (ISACB 2021, 17–18 September, Atlanta, USA).
The trial results showed advanced healing and remodelling of the Xeltis device into a living graft, with progressive replacement of the polymer with the animal’s own tissue, Xeltis said in a press release. The inner or lumen surface of the graft showed a smooth and confluent or filling endothelial cell lining, as a result of a homogeneous endothelialisation process. Endothelialisation is the final stage of healing in blood vessels, and most remarkably in this study it was seen along the full length of a 15cm long, 4mm inner diameter, device even at the mid-graft location.
“To my knowledge, it is the first time that long-term patency is observed in a synthetic CABG device in preclinical trials. The very promising safety and long-term preclinical performance of the Xeltis device is worth further evaluation in clinical phase,” said Richard Bianco, director of experimental surgery, University of Minnesota (Minneapolis, USA), a global leading expert in preclinical models and safety testing of synthetic implants.
In addition to featuring as one of three selected abstracts for the day, Xeltis devices were also included in a keynote speech by Fredrick Schoen, Harvard Medical School and Brigham and Women’s Hospital, Boston (USA) on restorative heart valves.