Tag Archive for: pivotal study

Xeltis expands Medical Advisory Board with World Leading Experts in Clinical Nephrology

Leading nephrologists Dr. An De Vriese and Dr. Monnie Wasse join as Company continues clinical advancement EINDHOVEN, The Netherlands, 11 March 2025 – Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, today announces the appointment of clinical nephrology experts An De Vriese, MD, PhD and Haimanot […]

Xeltis announces completion of enrolment in EU Pivotal Trial for aXess and prepares for market approval

Enrolment completed – 120 patients with end-stage renal disease in 22 centers in Europe Primary endpoint readouts anticipated in Q2 2025, first market approval expected in 2026 Capability to obtain market approval is further strengthened with the appointment of Rob Eyers as Chief Technology Officer. EINDHOVEN, The Netherlands, 7 January 2025 – Xeltis, a leading […]

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

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 […]

Xeltis appoints Shawn Gage as Vice President of US Clinical Affairs

Brings extensive experience in design, development, and implementation of US medtech clinical trial strategy for hemodialysis and vascular access Follows expansion of Xeltis’ clinical presence in the US after recent IDE approval for aXessTM US pivotal trial EINDHOVEN, The Netherlands, 23 July 2024 – Xeltis, a leading developer of transformative implants that enable the natural […]

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

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 […]