H&B 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.
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.