Remarkably positive one-year data from preclinical trials of Xeltis restorative coronary artery bypass graft (XABG) showed unprecedented patency for a synthetic small diameter graft device. The results showed that the device remained open to allow blood flow for 12 months in a challenging ovine model. These results were presented by Mohammed El-Kurdi, Xeltis Vice President for R&D Vascular, at the International Society for Applied Cardiovascular Biology (ISACB) 2021 meeting today.
In addition, 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. The inner or lumen surface of the graft showed a smooth and confluent or filling endothelial cell lining, as a result of a homogeneous endothelialization process. Endothelialization 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 Professor Richard Bianco, Director of Experimental Surgery, University of Minnesota (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 Professor Fredrick Schoen, Harvard Medical School and Brigham and Women’s Hospital, Boston (MA, USA), on restorative heart valves.
The International Society for Applied Cardiovascular Biology (ISACB) is devoted to enhancing discovery, development and clinical translation of cutting-edge biomedical science for innovative, state of the art cardiovascular diagnostic and therapeutic modalities. The ISACB 2021 meeting “Building Translational Bridges for Cardiovascular Patients” is taking place in Atlanta (GA, USA) on 17 and 18 of September.