Xeltis’ Post

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Today, Xeltis announces that the FDA has approved an Investigational Device Exemption (IDE) submission to begin enrolling patients in a pivotal study for #aXess.   This US-based pivotal trial follows strong 12-month data from a first-in-human study in Europe and marks a significant milestone in the company's clinical strategy.   aXess is a restorative conduit that allows the formation of a new living vessel for hemodialysis vascular access, providing a better dialysis patient experience. To learn more about the aXess US pivotal trial, see the press release in the comments section below. #FDA #VascularAccess #IDE

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Congratulations to Xeltis on this significant milestone!

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MCRA’s Cardio and Biocompatibility Regulatory teams are proud to have supported Xeltis with their IDE submission.

Peter Ohnemus

President & CEO at dacadoo | Providing unique digital health technology solutions for leading Life & Health insurers around the globe.

1mo

Congratutions to the Xeltis team - which are working so hard on providing better lives to heart patients.

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James Oberhauser, Ph.D.

Pharmaceutical and Medical Device Product Development Leader

1mo

Congratulations to the Xeltis team! I have been fortunate to be part of your journey for 9 years and look forward to IDE trial success.

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David Nii Kwartei Quartey

MSc/MA Innovation Design Engineering | Biomedical + Regenerative Engineer

1mo

Congratulations Xeltis team, encouraging news

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Mike Colson

Founder MC Biomedical Consulting, LLC

3w

great achievement by the team -- congratulations

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Christian van den Bos

SME Biologics/Advanced Therapeutics. Qualified Person (QP) for Gene/Cell/Tissue eng. Products. QP, pharmacovigilance.

1mo

Congrats to the Celtics team and much luck going forward!

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Joris Rotmans

Professor of Internal Medicine at Leiden University Medical Center

1mo

Well done Xeltis team, major step forward !

Congratulations! Look forward to seeing clinical cases in the US Paulo Neves

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