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.”
Notes to editors
About Chronic Kidney Disease
Chronic Kidney Disease (CKD) affects nine percent of the population, with growing prevalence due to cardiovascular disease (diabetes, hypertension, obesity). Patients with CKD have a reduced quality of life due to living with significant constraints and restrictions brought on by disease related manifestations and side effects of treatments. Each year, three million patients with chronic kidney disease need hemodialysis and require vascular access to connect to a dialysis machine.
About the aXess pivotal clinical trial
The EU aXess pivotal trial is a prospective multi-center study evaluating the safety and performance of the Xeltis hemodialysis access graft in patients with end-stage renal disease, who plan to undergo hemodialysis and are deemed unsuitable for fistula creation.
About Xeltis
Xeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels and valves. Xeltis’ devices seek to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year.
The Company’s proprietary endogenous tissue restoration (ETR) platform utilizes an a within and around it, before gradually being absorbed and leaving new, living and long-lasting vessels and valves in place. Xeltis’ devices currently under clinical development include aXessTM, implantable blood vessels for hemodialysis vascular access; XABGTM for coronary artery bypass graft (CABG) surgery; and Xplore 2TM for pediatric pulmonary heart valve replacement. Xeltis’ technology has high potential to be applied to other major vascular and cardiovascular diseases and represents a transformative technology for vascular and valve implants.
Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, and Ysios Capital, as well as Grand Pharma Group and several public and private investors.
Contacts
Xeltis
Eliane Schutte, CEO
Alexander Goemans, CFO
info@xeltis.com
Consilium Strategic Communications
Amber Fennell / Chris Welsh
+44 (0) 20 3709 5700
xeltis@consilium-comms.com
