Tag Archive for: dialysis

Xeltis announces FDA Breakthrough Device Designation for aXess and first patient treated in US pivotal trial

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Designation recognizes aXess has the potential of providing a more effective vascular access option for dialysis patients, bringing significant advantages over current therapies First patient treated in US pivotal trial, marking significant clinical milestone EINDHOVEN, The Netherlands, 14 November 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living […]

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Xeltis receives IDE approval from FDA for initiation of US pivotal trial for aXessTM, its restorative vascular access conduit

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aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, permanent, living vessel EINDHOVEN, The Netherlands, 13 June 2024 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announces that it has gained approval from the US […]

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Xeltis Announces Latest Results from aXess Trials to be Presented at 46th Annual Charing Cross Symposium

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Two key presentations by leading KOLs highlight positive results from aXess trials in adult patients with end-stage renal disease who need vascular access to hemodialysis aXess is a restorative arteriovenous dialysis conduit which allows vascular access for hemodialysis through the creation of a new, long-term living vessel EINDHOVEN, The Netherlands, 17 April 2024 – Xeltis, […]

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Invizius Treats First Patients in First-In-Human Phase 1 Clinical Study of Lead Dialysis Product H-Guard®

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First patients treated with H-Guard® at the National Institute for Health and Care Research Manchester Clinical Research Facility MHRA approves continuation of Invizius’s first-in-human clinical study following a prearranged two-patient safety and performance review Study is investigating safety and tolerability of H-Guard®, a second generation complement regulator, to address serious immune system-driven complications of dialysis […]

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Invizius Announces Appointment of World-Renowned Nephrologist Professor Bernard Canaud to its Clinical Advisory Board

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Invizius Limited (“Invizius”), a biotechnology company developing breakthrough treatments for patients on dialysis, is pleased to announce the appointment of Professor Bernard Canaud to its Clinical Advisory Board. Read more…

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