Xeltis has reported positive preliminary data for its Xabg coronary artery bypass conduit (CABG) in a clinical trial that is underway at various European Union (EU) sites.
The data from the trial indicated positive safety and patency for individuals with multi-vessel atherosclerotic coronary artery disease.
The human feasibility, single-arm study aims to assess the performance and safety of the Xabg technology in individuals who are scheduled for elective CABG surgery.
Developed leveraging the company鈥檚 Endogenous Tissue Restoration (ETR) platform, Xabg is a biorestorative, polymeric conduit that is said to facilitate continued blood flow in patients with coronary artery disease.
It has regenerative properties that allow living tissue to replace it over time gradually.
The company noted that CABG is invasive and often involves several vein grafts, which carry a significant risk of complications.
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By GlobalDataAccording to Xeltis, the EU trial has shown that Xabg functions with excellent flow in individuals, potentially negating the requirement for vein harvesting and helping in transforming bypass surgery, aiming for improved long-term durability.
Currently, there are no approved off-the-shelf, small-diameter vascular grafts with satisfactory patency rates. Xabg is expected to meet this critical need of suboptimal conduits in bypass surgery.
Xeltis’ chief medical officer Paulo Neves said: 鈥淭he encouraging safety and patency data is a major milestone for Xeltis and demonstrates that Xabg has the potential to significantly improve outcomes for patients with coronary artery disease.鈥�
An earlier separate trial showed that Xabg maintained patency with excellent flow for 24 months post-surgery.
This conduit represents the second product in the company鈥檚 clinical pipeline, after aXess, a restorative vascular access conduit currently in pivotal trials in the US and EU.
Last year, the US Food and Drug Administration granted an investigational device exemption to the company, clearing a pivotal study assessing aXess.
