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Avenu Medical logo and their medical devices

Avenu Medical

Avenu Medical announced that it has received De Novo marketing authorization from the Food and Drug Administration (FDA) to market its Ellipsys® Vascular Access System, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis. The FDA’s action will provide U.S. physicians and patients access to a unique nonsurgical option for arteriovenous (AV) fistula creation, a procedure that has not changed in over 50 years.

Announcing a Seismic Shift 50 years in the making  

Avenu Medical is a well-established medical device company dedicated to creating a paradigm shift in vascular access for hemodialysis patients. Our focus is to pursue unmet clinical needs by developing a minimally invasive, cost effective and efficient approach to vascular access.

Founded in 2010 and headquartered in Orange County, California, we have developed the Ellipsys® Vascular Access System, an innovative, image-guided, single catheter system used to percutaneously create an arteriovenous (AV) fistula for hemodialysis access (EndoAVF™).

The Ellipsys System is approved by the Food and Drug Administration (FDA) for EndoAVF creation. Approval was received after completing a pivotal clinical trial in the United States with one year patient follow-up.

The Ellipsys System has also received European CE Mark approval for the creation of an arteriovenous fistula in patients with chronic kidney disease requiring hemodialysis.

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