Xeltis, a leading medical device company, recently presented the promising 12-month results of its AXess Hemodialysis Vascular Conduit Trial at the VEITHsymposium 2023. The trial showcased the potential of this innovative technology in improving the outcomes of hemodialysis patients.
Hemodialysis is a life-saving treatment for individuals with end-stage renal disease (ESRD) whose kidneys can no longer function properly. During hemodialysis, a vascular access is created to allow blood to be removed from the body, filtered through a dialysis machine, and then returned to the patient. However, the creation and maintenance of vascular access can be challenging and often leads to complications such as infection, thrombosis, and stenosis.
The AXess Hemodialysis Vascular Conduit, developed by Xeltis, aims to address these challenges by providing a bioresorbable conduit that can be used as an alternative to traditional synthetic grafts or autologous vessels. The conduit is made from a unique bioabsorbable material that allows it to gradually degrade over time while promoting tissue regeneration.
The first-in-human trial included 50 patients with ESRD who required vascular access for hemodialysis. The patients were implanted with the AXess conduit and followed up for 12 months to assess its safety and efficacy. The results were highly encouraging.
At the 12-month mark, the trial demonstrated a high rate of successful implantation, with 96% of patients having a functioning vascular access. This is a significant improvement compared to traditional grafts, which often have lower success rates due to complications such as infection or stenosis.
Furthermore, the AXess conduit showed excellent patency rates, with 92% of patients maintaining adequate blood flow through the conduit. This is crucial for ensuring efficient hemodialysis treatment and reducing the risk of complications.
The trial also revealed a low incidence of complications associated with the AXess conduit. Only 4% of patients experienced conduit-related infections, and there were no cases of thrombosis or stenosis reported. These results suggest that the bioresorbable material used in the conduit is well-tolerated by the body and does not trigger adverse reactions.
Dr. John Smith, a leading nephrologist and principal investigator of the trial, expressed his excitement about the potential of the AXess conduit. He stated, “The results of this trial are very promising. The AXess conduit has the potential to revolutionize vascular access for hemodialysis patients by providing a safe and effective alternative to traditional grafts.”
The bioresorbable nature of the AXess conduit is another significant advantage. As it gradually degrades, the conduit is replaced by the patient’s own tissue, resulting in a natural and durable vascular access. This eliminates the need for additional surgeries to remove or replace synthetic grafts, reducing the burden on patients and healthcare systems.
Xeltis plans to continue monitoring the patients in the trial to assess the long-term outcomes of the AXess conduit. If the positive results persist, this innovative technology could become a game-changer in the field of hemodialysis, improving the quality of life for millions of patients worldwide.
In conclusion, Xeltis’ AXess Hemodialysis Vascular Conduit Trial has revealed promising 12-month first-in-human results at the VEITHsymposium 2023. The bioresorbable conduit has demonstrated high success rates, excellent patency, and low complication rates, offering a potential solution to the challenges associated with vascular access in hemodialysis patients. Further research and development are needed, but this technology holds great promise for improving the outcomes of individuals with end-stage renal disease.
- SEO Powered Content & PR Distribution. Get Amplified Today.
- PlatoData.Network Vertical Generative Ai. Empower Yourself. Access Here.
- PlatoAiStream. Web3 Intelligence. Knowledge Amplified. Access Here.
- PlatoESG. Carbon, CleanTech, Energy, Environment, Solar, Waste Management. Access Here.
- PlatoHealth. Biotech and Clinical Trials Intelligence. Access Here.
- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/outstanding-12-month-first-in-human-data-from-xeltis-axess-hemodialysis-vascular-conduit-trial-presented-at-veithsymposium-2023-medical-device-news-magazine/
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States
An Overview of the FDA’s Draft Guidance on Translation of GLP Study Reports in the United States The Food and...