Preclinical data on Xeltis restorative Coronary Artery Bypass Graft (CABG) device, XABG, show unprecedented one-year patency for a CABG device, potentially superior to saphenous veins.
It is the most prolonged patency ever demonstrated for a small-diameter (4mm diameter; 15cm length) CABG device in large animals. The data have been published in JACC: Basic to Translational Science Journal (JACBTS).
The one-year XABG results consistently demonstrated widely patent grafts (n=5), which were uniformly open and with no dilations, unlike the saphenous veins in the control group (n=3). For the first time, it was therefore shown that a restorative synthetic small-diameter graft can outperform animal’s own saphenous vein grafts in a rigorous preclinical CABG study.
The trial used the most sophisticated analysis techniques, including angiography, OCT and IVUS imaging modalities. The published data also showed new tissue formation at one year, confirming the restorative properties of this first-of-its-kind synthetic graft.
“If these results are confirmed in clinical settings, XABG may have a major impact on CABG surgery treatment, by enabling surgery in currently unsuitable patients, and also by potentially reducing operation risks and recovery in all patients,”
stated Professor Patrick W. Serruys, Department of Cardiology, National University of Ireland, Galway (IR).
Despite the drawbacks, saphenous veins are used in over 80 percent of CABG procedures worldwide.
XABG is currently in clinical trials as part of Xeltis’ small-diameter vessels trial program. Xeltis’ trials also include the First-in-Human study of the restorative vascular access graft for hemodialysis, aXess.
“The XABG outcomes, and their recognition by the scientific community, are valuable milestones for our program,” said Eliane Schutte, Xeltis CEO. “XABG and aXess, our restorative small-diameter vessels, are the most advanced devices of their kind.”