Success Stories

CLIENT SPOTLIGHT

AVENU MEDICAL

Hutchinson and Bloodgood LLP Partner: Hanne LeLoup, San Diego

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 Years in the making

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.

Hanne LeLoup, Partner

Hutchinson and Bloodgood LLP 
Hanne LeLoup, Partner in Charge
San Diego, CA
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