Who needs hemodialysis?
When people have end-stage renal disease, their kidneys are no longer able to clean their blood from waste that normally builds up in the body.
These patients need regular access to an external filtering machine, or dialyzer, to work in place of their kidneys.
What is hemodialysis access?
The dialysis machine is connected to the patient’s body by piercing a so-called vascular access in their blood vessels.
During the session, the vascular access enables a sustained blood flow to and from the dialysis machine.
Human vessels are not naturally strong and large enough for repeat puncturing and for the dialyzer’s high blood flow.
The vascular access must be created, usually in the patient’s arm or neck, with a minor surgery.
Current access options
Today, hemodialysis access options include:
AVF – Fistula
An arteriovenous fistula (AVF) is a passage created by joining and enlarging an artery and a vein in the patient’s arm.
It is generally a longer lasting option.
AVG – Synthetic graft
An arteriovenous graft (AVG) is a small plastic tube implanted in the patient’s arm to connect an artery and a vein. Grafts can be used promptly: some just a few days after implanting and most within three weeks.1Schwab SJ et al. Vascular access for hemodialysis. Kidney International. 1999 May;55(5):2078-90. doi: 10.1046/j.1523-1755.1999.00409.x. PMID: 10231476.
CVC – Catheter
A central venous catheter (CVC) is a larger tube implanted in the patient’s neck to provide access to larger veins. It provides immediate dialysis access – the most suitable option for emergencies.
The limitations of existing options
Unfortunately, all existing options have their limitations:
AVF – Fistula
- Takes time to develop or mature: four weeks to four months.
- Many fail to mature (up to 60 percent)2Venkat Ramanan S et al. Outcomes and predictors of failure of arteriovenous fistulae for hemodialysis. Int Urol Nephrol 54, 185–192 (2022). https://doi.org/10.1007/s11255-021-02908-5
AVG – Synthetic graft
- Tends to bend and narrow
- Likely to increase risk of infection and blood clot3Roetker, NS et al. Hemodialysis Vascular Access and Risk of Major Bleeding, Thrombosis, and Cardiovascular Events: A Cohort Study, Kidney Medicine, Volume 4, Issue 6, 2022, 100456, ISSN 2590-0595, https://doi.org/10.1016/j.xkme.2022.100456
CVC – Catheter
- Has highest risk of infection and blood clot, as its tip is located near the heart4Wilcox TA. Catheter-related bloodstream infections. Semin Intervent Radiol. 2009 Jun;26(2):139-43. doi: 10.1055/s-0029-1222458. PMID: 21326505; PMCID: PMC3036424.
A better option would be very much needed to improve patient’s treatment and overcome current drawbacks.
The aXess graft
The aXess graft is a new, restorative, synthetic device for vascular access that overtime turns into a living blood vessel.
How the aXess graft works
The aXess graft can be used promptly once implanted, like synthetic grafts
In time, it turns into a living blood vessel made of patient’s own tissue, similar to a fistula
This may potentially:
Reduce the risk of complications and replacement compared to existing grafts
Enable dialysis access to patients who cannot have a fistula
The aXess graft restorative technology
The aXess graft has a porous structure that gets colonized by the patient’s tissue cells overtime
It is made of special synthetic materials or polymers that gradually absorb in the body
The aXess graft results date
The aXess graft has been implanted in 20 patients as part
of an ongoing First-in-Human research study
Over 3500 dialysis sessions have been enabled to date as part of this study5Company data on file
As part of the FIH trial, the aXess graft showed:6Moll F. ‘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 (From Xeltis)’ Presented at 50th Veith Symposium in New York City (NY – USA) on 16 November 2023
• 100 percent dialysis functionality (secondary patency)
• no infections
one year after implanting in these patients
The aXess Pivotal Trial
The aXess Pivotal trial is an ongoing research study that will help understand how the new restorative vascular access conduit, aXess, works in patients with end-stage kidney disease that need hemodialysis.
The study is aiming to enroll 110 adult patients in 25 centers in Europe and is actively recruiting now.
Who may be considered for the study?
- Patients with end-stage renal disease requiring an access graft to begin or continue hemodialysis
- At least 18 years of age at screening
- With suitable physical structure to be implanted an aXess conduit
- Who need hemodialysis within six months
- Who are expected to live for at least a year
Some conditions, among others, prevent participation
- Serious heart disease
- Poorly controlled diabetes
- Blood values that could make recovery difficult
- Poorly functioning liver
- Active infection
- Reduced platelets due to Heparin use
- Bleeding or coagulation issues
- Allergies to nitinol or contrast agents or aspirin
- Expected kidney transplant within six months
- Central vein obstruction on the side of the arm to be implanted
- Previous dialysis access graft in the arm to be implanted
- Previous participation to this or other vascular access studies
- Pregnancy or breastfeeding
For full study information and details please visit:
www.clinicaltrials.gov Study Number NCT05473299.
To learn more about Xeltis, the study sponsor, please visit www.xeltis.com
