July 9th, 2019 Medgadget Editors Medicine

To perform hemodialysis, vascular access needs to be available on a regular basis. Veins are naturally too fragile for this, but arteries are too deep seated to be tapped frequently. Arteriovenous (AV) fistulas, which link an artery and a nearby vein, are typically created to overcome this since after only a few weeks the vein becomes much more resilient.

Probably the most nerve wrecking, painful, and critical step during a dialysis session is placing the needle into the AV fistula. Complications are frequent and patients generally hate this step, whether it goes well or not.

Advent Access, a company based in Singapore, has just won the European CE Mark allowing it to introduce its av-Guardian vascular access system, which radically changes how hemodialysis is normally performed.

It involves placing two implants under the skin that can offer long-term, reliable access to the vasculature. This will hopefully reduce trauma to the AV fistula, lowering complication rates, and resulting in less pain and other problems.

One of the possibilities with the new approach is that it will allow more patients to receive dialysis at home, as patients will be able to access their blood confidently using a needle.

The vein is not actually in contact with the implants. They simply provide a “guardian guide-door” to be able to reach the AV fistula without problems. It should be compatible with all types of dialysis setting and will work with any machine.

Some details about a recent study of the av-Guardian system, according to Advent Access:

The av-Guardian™ technology was recently evaluated in a first-in-man study conducted at Singapore General Hospital and the National University Hospital of Singapore, with support from the National Kidney Foundation. The study was a non-randomized, prospective clinical investigation to assess the safety and clinical performance of the av-Guardian™ across 216 hemodialysis sessions in patients with native AV fistulas. The study showed that av-Guardian™ met all safety and performance endpoints. In particular, the av-Guardian™ achieved 94% – 98% successful access to the AV fistula, with 86% – 90% success at the first needle attempt.

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Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.