PROFESSIONALS

A hybrid vascular access solution

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.

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The aXess Pivotal Trial

Hemodialysis Access Today

Today, patients with end-stage renal disease (ESRD) who need hemodialysis have a few vascular access options, unfortunately each has their limitations.

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Current Options

AVF

Arteriovenous Fistulas

  • Require several weeks to several months to mature [1]
  • Mature and well-functioning fistulas have the lowest infection and thrombotic risk rates vs other options [1]
AVG

Arteriovenous Grafts

  • Can be punctured promptly after implant
    (ranging from immediately to 3-4 weeks)
  • More prone to infection and patency loss
    compared to fistulas [1]
  • Associated with higher reintervention
    and mortality risks. [1]
CVC

Central Venous Catheters

  • Associated with highest infection and mortality rates
  • Tend to be used when alternatives are not viable [2]
  • More than 80% of incident ESRD patients in the US initiate HD with a CVC [3]

Although they serve as a lifeline for many patients, existing vascular access options account for high patient morbidity and mortality.

A better solution to improve infection and intervention rates in ESRD patients is needed.

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SOLUTION

aXess – a hybrid solution 

Vascular Access Conduit

aXess is a novel, synthetic vascular access device under investigation that, when implanted into patients, transforms into a living blood vessel over time.

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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.

aXess is a sterile conduit with a 6mm inner diameter made of a highly porous polymer matrix, reinforced by a, thin, embedded nitinol mesh for kink resistance.

  • Restorative – In time, aXess gets colonized by patient cells and tissue, becoming a living blood vessel, similar to a fistula, and with its own microvasculature.
  • Biodegradable polymers – Its porous structure is made of electrospun supramolecular polymers that eventually resorb in the body and become replaced by host vascular tissue such as vascular smooth muscle cells and an endothelial lining.
  • Flexibility – aXess supports both straight and loop configurations and may be implanted in the upper arm and forearm
  • Ease of use – It can be punctured approximately 2 weeks after implant

Restorative Technology

aXess has a porous structure that becomes colonized by the patient’s own vascular smooth muscle and endothelial cells and tissue overtime.

It is made of special synthetic materials or polymers (each much smaller than a human hair) that gradually absorb in the body.

Results to Date

20 patients

First-in-Human (FIH) trial

  • Ongoing first-in-human trial aXess.
  • Twenty patients implanted
  • Six European centers in Belgium,
    Italy, Latvia and Lithuania
  • Over 5000 dialysis sessions enabled [3]

2 Year Results

As part of the FIH trial,
the aXess graft showed

  • Two years after their interventions, the aXess device was still working well in most of them (secondary patency: 80% vs average 54% of grafts).
  • It didn’t cause any infections and very few of them needed to be replaced.

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 a prospective, single arm, multi-center study to evaluate the safety and performance of the aXess graft in adult patients with ESRD who need hemodialysis.

The study will enroll 140 patients in up to 20 centers across the United States and will follow them for five years.

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

Inclusion criteria comprise, among others:

  • ESRD patients requiring AVG to start or maintain hemodialysis therapy
  • At least 18 years of age at screening
  • Suitable anatomy for an aXess graft implantation (e.g. target vein with at least 5mm minimum diameter and adequate arterial inflow)
  • Life expectancy of at least 12 months

Exclusion criteria comprise, among others:

  • History or evidence of severe cardiac disease, myocardial infarction, ventricular tachyarrhythmias or unstable angina
  • Poorly controlled diabetes
  • Significant liver dysfunction
  • Active local or systemic infection
  • Known heparin-induced thrombocytopenia
  • Known active bleeding disorder, coagulopathy or thromboembolic disease
  • Allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin
  • Anticipated renal transplant within six months
  • Known or suspected central vein obstruction on the side planned for graft implantation
  • Previous dialysis access graft in the operative limb unless the aXess graft can be placed more proximally
  • Previous enrolment in this study or concurrent enrollment in another study
  • Pregnancy or breastfeeding

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