Summation
- “The 12-month data from the aXess FIH trial are highly encouraging, and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG, such as early cannulation and no maturation needed, with the long-term advantages of AVF, including better patency rates, a reduced need for intervention and low infection rates.
- The aXess FIH trial is a single arm feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in subjects older than 18 years with end-stage renal disease and deemed unsuitable for fistula creation.
- “The outstanding 12-month data from our FIH study highlights aXess' potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections.
Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces outstanding 12-month data from its first-in-human (FIH) aXess vascular conduit trial (NCT04898153). The data was presented yesterday by Prof. Dr. Frans Moll at the 50th Annual VEITHsymposium in New York.
At 12 months, 100% secondary patency, 78% primary assisted patency and 0% infections were observed in data from 20 patients implanted with the aXess conduit. These outstanding results represent a significant improvement over current standard of care. This performance builds on the very encouraging 6-month data presented in April 2023 at the Vascular Access Society Congress in Porto, Portugal. To date, more than 3500 dialysis sessions have been conducted across the six centers in Belgium, Italy, Latvia and Lithuania.
aXess is a restorative conduit which enables the creation of a new, long-term living vessel for hemodialysis vascular access. The aXess FIH trial is a single arm feasibility study in Europe evaluating the preliminary safety and performance of the aXess graft in subjects older than 18 years with end-stage renal disease and deemed unsuitable for fistula creation. Follow-up visits were conducted at regular intervals after the initial procedure, with study follow-up visits to be conducted for five years. A separate pivotal trial of aXess is underway, enrolling up to 110 patients across up to 25 sites in nine EU countries, with over 40 patients already implanted.
The full data were presented today by Prof. Dr. Frans Moll, Department of Vascular Surgery, University Medical Centre Utrecht, The Netherlands, in a presentation entitled: Novel Application Of Polymer Technology To Create Endogenous Tissue with Host Collagen And Endothelium Compatible With Flowing Blood: 1-Year Clinical Results Of The aXess Graft.
Professor Dr. Frans Moll, vascular surgeon and member of Xeltis’ Medical Advisory Board, said: “The 12-month data from the aXess FIH trial are highly encouraging, and continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG, such as early cannulation and no maturation needed, with the long-term advantages of AVF, including better patency rates, a reduced need for intervention and low infection rates.”
Eliane Schutte, CEO of Xeltis commented: “The outstanding 12-month data from our FIH study highlights aXess’ potential to transform the field of vascular access as a whole by stopping the cycle of interventions and infections. These latest results, alongside the excellent progress in enrollment for our pivotal trial, brings us closer to bringing our breakthrough solution to hemodialysis patients worldwide.”