A Comprehensive Guide to Clinical Investigations: Content and Modifications in the EU – MDCG Guidance

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Xeltis’ AXess Hemodialysis Vascular Conduit Trial Presents Impressive 12-Month First-in-Human Data at VEITHsymposium 2023 – Medical Device News Magazine

Xeltis’ AXess Hemodialysis Vascular Conduit Trial Presents Impressive 12-Month First-in-Human Data at VEITHsymposium 2023

Medical Device News Magazine recently reported on the groundbreaking results of Xeltis’ AXess Hemodialysis Vascular Conduit Trial, which presented impressive 12-month first-in-human data at the VEITHsymposium 2023. This trial has the potential to revolutionize the field of hemodialysis and improve the lives of millions of patients worldwide.

Hemodialysis is a life-saving treatment for patients with end-stage renal disease (ESRD) who have lost kidney function. It involves the use of a vascular conduit, typically made from synthetic materials, to connect an artery and a vein, allowing for the removal of waste products and excess fluids from the body. However, these synthetic conduits often lead to complications such as infection, thrombosis, and stenosis, which can significantly impact patient outcomes.

Xeltis, a Swiss medical technology company, aims to address these challenges with its innovative AXess Hemodialysis Vascular Conduit. Unlike traditional synthetic conduits, the AXess conduit is made from a bioabsorbable material called Xeltis’ Endogenous Tissue Restoration (XETR) technology. This unique material is designed to mimic the body’s natural healing process, allowing for the regeneration of functional blood vessels.

The first-in-human trial, presented at the VEITHsymposium 2023, included 50 patients with ESRD who required hemodialysis. The results were nothing short of impressive. At the 12-month follow-up, the AXess conduit demonstrated excellent patency rates, with no instances of thrombosis or stenosis observed. Additionally, there were no reported cases of infection or other complications typically associated with synthetic conduits.

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 truly remarkable. The AXess conduit has the potential to revolutionize hemodialysis access and significantly improve patient outcomes. The absence of complications such as thrombosis and infection is particularly promising.”

The AXess conduit’s bioabsorbable nature is another significant advantage. Unlike synthetic conduits that remain in the body indefinitely, the AXess conduit gradually absorbs over time, leaving behind a regenerated blood vessel. This eliminates the need for additional surgeries to remove or replace the conduit, reducing the risk of complications and improving patient convenience.

Xeltis plans to conduct further clinical trials to gather more data on the safety and efficacy of the AXess conduit. If successful, this innovative technology could become the new standard of care for hemodialysis access, benefiting millions of patients worldwide.

In conclusion, Xeltis’ AXess Hemodialysis Vascular Conduit Trial presented impressive 12-month first-in-human data at the VEITHsymposium 2023. The trial showcased the potential of this bioabsorbable conduit to revolutionize hemodialysis access by reducing complications and improving patient outcomes. With further research and development, the AXess conduit could become a game-changer in the field of medical devices and significantly enhance the lives of patients with end-stage renal disease.

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