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Medical Devices / Submissions and Approvals

Advent Access Earns CE Mark for Vascular Access System

July 8, 2019
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Singapore-based Advent Access  earned the CE Mark for its av-Guardian vascular access system, which allows dialysis needles to access the arteriovenous fistula using a “guardian guide door” without being in contact with the vein.

In a recent study, the av-Guardian met all safety and performance endpoints and achieved 94-98 percent successful access, mostly with the first needle attempt.

The technology can be used in dialysis centers or at home and with any dialysis machine.  Reliable access to the arteriovenous fistula is a challenging part of hemodialysis, with frequent complications caused by poor needling.

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