Netherlands and US-based medtech company Xeltis tells us about its first-in-human (FIH) vascular conduit trial for hemodialysis access. Vascular surgeon Prof. Dr. Frans Moll presented the data at the 50thAnnual VEITH symposium in New York. In a subsequent news release the company describes the 12-month data from its aXess vascular conduit trial (NCT04898153) as outstanding.
Background
Netherlands-based Xeltis is developing artificial vessels and valves that are gradually replaced by patients’ own living healthy tissue. In other words these are termed “transformative” implants that enable the natural creation of living and long-lasting vessels.
Xeltis is targeting 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 advanced polymer implant. The polymer acts as a scaffold for the patient’s own tissue before gradually disappearing through absorption. This results in new, living and long-lasting vessels, in contrast with other synthetic vascular implants. Xeltis’ most advanced product currently under clinical development is aXessTM. The aXess graft enables the creation of a new, long-term living vessel for hemodialysis vascular access.
Hemodialysis Access Study
The aXess FIH trial is a single arm feasibility study in Europe. It is evaluating the preliminary safety and performance of the aXess graft in subjects older than 18 years. Subjects are suffering end-stage renal disease and deemed unsuitable for fistula creation.
Follow-up visits took place at regular intervals after the initial procedure. These will continue for five years. Furthermore a separate pivotal trial of aXess is underway. This will enrol up to 110 patients across up to 25 sites in nine EU countries. Over 40 patients have already undergone implantation.
Of 20 patients with the aXess conduit, 12 month data showed 100% secondary patency, 78% primary assisted patency and 0% infections. In conclusion, Xeltis says these outstanding results represent a significant improvement over current standard of care. Furthermore 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 investigators have conducted more than 3500 dialysis sessions across the six centers in Belgium, Italy, Latvia and Lithuania.
Prof. Dr. Frans Moll, Department of Vascular Surgery, University Medical Centre Utrecht, The Netherlands presented the data. His paper was titled: 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.
Clinician comments
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. They continue to demonstrate the potential of the aXess vascular conduit to combine the early benefits of AVG. These include early cannulation and no maturation needed.”
In addition he spoke about, “the long-term advantages of AVF. These include better patency rates, a reduced need for intervention and low infection rates.”
Company comments
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.”
Source: Globe Newswire
published: December 7, 2023 in: Clinical Studies/Trials, News, Vascular