Avenu Medical Unveils Ellipsys – a Non-Surgical Fistula Creation System

Live Simulcast Procedure at CiDA Avenu’s Endovascular Arteriovenous Fistula (endoAVF™) Technology for ESRD Patients Receives Favorable Medicare Reimbursement Code while Exhibiting at Controversies in Dialysis Access Meeting

The FDA-approved Ellipsys® Vascular Access System from Avenu Medical, Inc., became a key focus of attention throughout last week’s Controversies in Dialysis Access (CiDA) 15th Anniversary Meeting, thanks to a crowd-drawing live simulcast of an endoAVF procedure and breaking news of a Medicare HCPCS C-code for reimbursement for the technology and procedure.

Ellipsys, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease (ESRD) patients requiring hemodialysis, provides physicians and patients access to a unique non-surgical option for arteriovenous (AV) fistula creation, a procedure that had not previously changed in over 50 years.

As a highlight of the annual CiDA meeting, day two of the conference featured two of the pioneers of endoAVF, Jeffrey Hull, M.D. of Richmond Vascular Center, and Alexandros Mallios, M.D. of L’Institut Mutualiste Montsouris in Paris, France. Dr. Mallios performed a live procedure utilizing Ellipsys that was simulcast in real-time via Dr. Mallios’ operating room. More than 350 leading vascular access specialists gathered at the conference to observe the presentation.

“We are very encouraged by the consistent positive results we’ve been seeing in Ellipsys patients,” said Dr. Hull. “It was rewarding to be able to share our experiences with our peers here at CiDA, demonstrate this innovative technique in real time and to receive such an enthusiastic reaction from the conference attendees.”

“Ellipsys is truly revolutionary because it is a non-surgical fistula creation that can provide good vascular access while reducing the pain and suffering associated with traditional fistula surgery,” added Dr. Mallios, a vascular surgeon who previously performed only surgical fistulas. “We believe this new technique and technology will have a tremendous positive effect on the worldwide ESRD population that needs this procedure.”

While at the conference, Avenu also received confirmation that the Ellipsys System received its Medicare HCPCS reimbursement C-code in a final rule by CMS, effective January 1st, 2019.

“What a rewarding experience to receive a C-code right as we are presenting our technology at CiDA, one of the premiere dialysis access medical conferences in the world,” said Ed Chang, Avenu’s Co-Founder and VP of Marketing. “We are grateful to CMS for its foresight in creating a fair and reasonable reimbursement scenario. This will make vascular access for hemodialysis more widely available to the underserved ESRD patient population nationwide, signaling a significant quality-of-life improvement for patients and their loved ones.”

Also on Friday, Avenu Medical hosted a special CiDA industry session titled, “Using the Ellipsys System for EndoAVF Creation: Techniques, Results and Outcomes.” Clinical faculty for the session were interventional radiologist John Aruny, MD of Orangeburg, SC; and vascular surgeons William Jennings, MD of Tulsa, OK; John Ross, MD of Orangeburg, SC; and Robert Shahverdyan, MD of Hamburg, Germany.

The Ellipsys System also had a dedicated station as part of the annual Simulation of the Dialysis Access (SoDA) interactive course which took place prior to the start of CiDA. At this hands-on station, attendees used ultrasound to simulate pre-operative vessel mapping and then trained on the Ellipsys System to learn the technique of EndoAVF creation. Avenu Medical exhibited the Ellipsys System throughout the CiDA conference.

A significant advancement for dialysis patients and clinicians, the Ellipsys System transforms an open surgery connecting an artery to a vein into a minimally invasive procedure using a needle and a catheter. Using a percutaneous approach, the Ellipsys procedure replaces an incision with a needle puncture, surgical dissection with ultrasound imaging, and sutures with tissue fusion. The procedure can be performed in the physician’s office, but will also be used in hospitals and ambulatory surgery centers. After the procedure, the patient leaves with just a band-aid.

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