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A hybrid vascular
access solution

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 none of which are ideal.

Arteriovenous fistulas

  • Require four to six weeks to mature 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.
  • Mature fistulas have the lowest infection and thrombotic risk rates vs other options.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.

Arteriovenous grafts

  • Can be punctured promptly after implant
  • More prone to infection and patency loss compared to fistulas1Schwab 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.
  • Associated with higher reintervention and mortality risks.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.

Central venous catheters

  • Associated with highest mortality rates
  • Tend to be used when alternatives are not viable2Wilcox TA. Catheter-related bloodstream infections. Semin Intervent Radiol. 2009 Jun;26(2):139-43. doi: 10.1055/s-0029-1222458. PMID: 21326505; PMCID: PMC3036424.

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

A better solution to improve survival rates in ESRD patients is needed.

The aXess graft
– a hybrid solution

The aXess graft is a novel, synthetic vascular access device that turns into a living blood vessel over time.

Watch how aXess works

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

Restorative

In time, aXess gets colonized by patient tissue cells, becoming a living blood vessel, like a fistula

Biodegradable polymers

Its porous structure is made of electrospun supramolecular polymers that eventually resorb in the body

Flexibility

The aXess graft supports both straight and loop configurations and may be implanted in the upper arm and forearm

Ease of use

It can be punctured promptly after surgery, like synthetic grafts

The aXess graft is designed to potentially reduce infection and reintervention rates compared to existing AVGs and to improve vascular access options in ESRD patients who are unsuitable for fistulas.

Results to date

First-in-Human (FIH) trial

  • Ongoing first-in-human trial aXess.
  • Twenty patients implanted
  • Six European centers in Belgium, Italy, Latvia and Lithuania
  • Over 3500 dialysis sessions enabled3Company data on file
  • Outstanding results at 12 months 4Moll 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
  • Secondary patency: 100 percent
  • Primary assisted patency: 78 percent
  • Infections: none

The aXess Pivotal Trial

The aXess 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 110 patients in up to 25 centers in Europe and will follow them for five years.

Trial centers are actively enrolling.
Please contact the center nearest to you for further information or to refer a patient.

Find enrolling centers

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)
  • 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
  • Abnormal blood values that could influence recovery or hemostasis
  • Reduced liver function
  • 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 another study
  • 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