CE Mark for av-Guardian vascular access system
Advent Access announced receipt of the CE Mark certificate for its award-winning av-Guardian vascular access system. The certificate indicates av-Guardians conformity with health, safety, and environmental protection standards set by the European Union for a device to be distributed into the European Economic Area. The av-Guardian is the world’s first implant technology to pioneer the concept of establishing a “guardian guide-door” to facilitate dialysis needles to optimally access the dialysis vein, an arteriovenous fistula (AV fistula), without being in contact with the vein. The technology is compatible with patients undergoing hemodialysis in various treatment settings – in dialysis centers or at home, regardless of the types of dialysis machine being used.
Comment: To perform hemodialysis, vascular access needs to be available on a regular basis. Veins are 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 sensitive, painful, and critical step during a dialysis session is placing the needle into the AV fistula. Complications are frequent and patients generally strongly dislike this step, whether it goes well or not.
Advent Access, now will 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.
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