Feb 27, 2019   SOURCE: BusinessWire

Ellipsys System for Non-Surgical Fistula Creation Used to Treat Veterans

The Chief of Surgery at the Jack C. Montgomery VA Medical Center, Dr. Mark Randel, recently performed a new revolutionary vascular procedure for patients requiring hemodialysis, a treatment necessary for patients with kidney failure. Using the Ellipsys® Vascular Access System, Dr. Randel and potentially other VA physicians around the nation can now create a percutaneous arteriovenous fistula (AVF), a less invasive innovation for patients with End-Stage Renal Disease (ESRD). The Jack C. Montgomery VA Medical Center is the first VA facility to offer this procedure.

“This is a very innovative way of creating vascular access,” said Dr. Randel in an interview with VAntage Point, the official blog of the US Department of Veterans Affairs. “It’s a game-changer, and it transforms a commonly performed traditional surgery into a minimally invasive procedure that will benefit the veterans we serve.”

The recently FDA-cleared Ellipsys System gives physicians a unique non-surgical option for AVF creation, a procedure that had previously not changed in over 50 years. A revolutionary advancement for dialysis patients and clinicians, the Ellipsys System, developed by Avenu Medical (San Juan Capistrano, CA), transforms an open surgery connecting an artery to a vein into a minimally invasive procedure using a needle and a catheter. Unlike the common surgical method, the new procedure uses an endovascular approach (endoAVF) whereby the Ellipsys catheter is advanced through the skin and into a vein, under ultrasound, to create the access needed for dialysis. This “band-aid fistula” leaves the skin without a scar and the tissue undisturbed. As a result, the Ellipsys technology enables clinicians to perform AVF creations in a manner that is a simpler, more efficient and less-invasive option for patients requiring vascular access.

News of the successful procedures at the VA Medical Center is followed by Avenu receiving a US Federal Contractors Service Agreement that gives the company the ability to provide the Ellipsys technology to more Veterans Administration facilities nationwide.

“We are incredibly proud that the heroes of our nation, our military veterans, are among the first to receive this state-of-the-art treatment so they can get the care they need and deserve,” said Ed Chang, Avenu’s Co-Founder and VP of Marketing. “Although ESRD is a global problem, the prevalence rate of ESRD among veterans is significantly higher than the general population. Therefore, working with the VA, we can directly address this pressing clinical need and take major steps toward fulfilling a treatment gap.”

“This new method has a very high success rate and low complication rate,” added Dr. Peter Nelson, VA Physician and Chief of the Vascular Surgery Division at the University of Oklahoma (OU). “There are a lot of dialysis needs in the VA and a huge population of veterans will benefit from this new process.”

Media: To arrange interviews or to receive more information about the new Ellipsys Vascular Access System, please contact Paul Williams at 310/569-0023 or paul@medialinecommunications.com.