A new way to access hemodialysis
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.
Who needs hemodialysis?
When people have end-stage renal disease (ESRD), 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 a hemodialysis access?
The dialysis machine is connected to the patient’s body by placing dialysis needles into a so-called vascular access in their blood vessels.
During the session, the vascular access enables sustained blood flow to and from the dialysis machine.
Human blood vessels are not naturally strong or large enough to endure repeated puncturing or to handle the high blood flow required by the dialyzer.
Vascular access must be created, usually in the patient’s arm, with a minor surgery.
Current Options
Today, hemodialysis access options include:
AVF
Arteriovenous Fistulas
An arteriovenous fistula (AVF) is a passage created by joining a vein to an artery in the patient’s arm, which then must dilate and enlarge. It is generally accepted as a longer lasting option.
Limitations
- Takes time to develop or mature:
four weeks to four months. - Many fail to mature for use (up to 60 percent) [2]
AVG
Arteriovenous Grafts
An arteriovenous graft (AVG) is a small tube (typically Teflon plastic) 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 to four weeks. [1]
Limitations
- Unable to heal and do not last as long as AVF
- Likely to increase risk of infection and access occlusion (clotting) [3]
CVC
Central Venous Catheters
A central venous catheter (CVC) is a longer tube inserted in the patient’s neck or chest to provide access to larger veins. It provides immediate dialysis access – the most suitable option for emergent access.
Limitations
- Has highest risk of infection and clotting, as it is an external tube with direct and constant access to the blood stream. [4]
Although they serve as a lifeline for many patients, existing vascular access options account for high patient morbidity and mortality.
There is a significant need for a better option to enhance patient treatment and address these limitations.
SOLUTION
aXess – for hemodialysis
Vascular Access Conduit
aXess is an innovative vascular access device currently under investigation that is designed to initially function as a synthetic graft, but progressively transform into a living blood vessel.
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Watch How aXess Works
aXess is designed to potentially reduce infection and reintervention rates compared to existing AVGs and to improve vascular access options in ESRD patients.
How aXess Works
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aXess can be used approximately 2 weeks after implant similar to synthetic grafts.
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In time, aXess is designed to turn into a living blood vessel made of patients’ own cells and tissue, similar to a fistula.
This may potentially
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Reduce the risk of complications, infections, and the need for replacement compared to existing graft options
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Enable a more natural dialysis access option to patients who cannot have a fistula
Restorative Technology
aXess has a porous structure designed to become colonized by the patient’s own cells and tissue over time
It is made of special biodegradable synthetic materials (or polymers) that gradually absorb in the body.
aXess FIH (First in Human) Results to Date
20 patients
aXess First in Human Study
- aXess has already been implanted in 20 patients as part of an ongoing First-in-Human clinical study
- Over 5000 dialysis sessions have been performed to date as part of this study [3]
2 Year Results
As part of the FIH trial,
the aXess graft showed
- Excellent patency
- Secondary patency: 80% (vs average 54% of grafts)
- Excellent safety profile
- No infections
- Low reintervention rates
- Six centers in Belgium, Italy, Latvia and Lithuania
The follow up is ongoing for this study and some patients are now beyond 4 years of use of aXess.
120 patients
aXess European Pivotal Study
Xeltis recently completed enrollment of 120 patients in the European pivotal clinical study. In this study patients were treated in several countries in Europe, further expanding use and experience with the Xeltis aXess technology.
This study is in ongoing follow up and some patients are now in follow up beyond 2 years. Initial study results are on track to be available in late 2025.
axesspivotal.com
The aXess United States Pivotal Trial
The aXess US Pivotal trial is an ongoing clinical study that will evaluate the safety and performance of the investigational restorative vascular access conduit, aXess, in patients with ESRD that need hemodialysis.
The study is now actively recruiting and is aiming to enroll 140 adult patients in up to 20 centers across the United States.
140
Patients Enrolling
20
Centers Across US
5
Five Year Patient Follow-up
Trial centers are actively enrolling
Please contact the center nearest to you for further information or to refer a patient.
Enrolling Centers
Enrolling Criteria
Who may be considered for the study?
- Patients with ESRD requiring an access graft to begin or continue hemodialysis
- At least 18 years of age at screening
- With suitable physical structure and blood vessels to be implanted with aXess
- Who will 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
- Poorly functioning liver
- Active infection
- Bleeding or coagulation (clotting) 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
- Pregnancy or breastfeeding
For more information on the aXess Hemodialysis Conduit, download the Patient Recruitment Leaflet
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aXess Patient Recruitment Leaflet
For full study information and details please visit www.clinicaltrials.gov Study Number NCT06494631
To learn more about Xeltis, the study sponsor, please visit www.xeltis.com
