Local Interventional Nephrologists Randy Cooper, M.D. and Umar

Waheed, M.D., Pioneer Breakthrough Endovascular Arteriovenous Fistula

(endoAVF®) Technology for ESRD Patients

TEMPE, Ariz.--(BUSINESS WIRE)--Tempe-based interventional nephrologists Randy Cooper, MD and Umar

Waheed, MD, and their team at SKI

Vascular Center, this week became the first ambulatory surgical

center in the US to create a percutaneous arteriovenous fistula (AVF),

using the Ellipsys® Vascular Access System, a game-changing innovation

for patients with End-Stage Renal Disease (ESRD).

The recently FDA-approved Ellipsys System is a minimally-invasive,

single catheter-based system designed for ESRD patients requiring

hemodialysis. Pioneered in Arizona by Drs. Cooper and Waheed, the new

procedure and technology bring patients a unique non-surgical option for

AVF creation, a procedure that had previously not changed in over 50

years.

A significant 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. Using a percutaneous approach, the Ellipsys

procedure replaces an incision with a needle puncture, ultrasound

imaging replaces surgical dissection, and sutures are replaced with

tissue fusion. The procedure can be performed in a physician-based

procedural center, but can also be used in hospitals and ambulatory

surgery centers. After the procedure, the patient leaves with just a

band aid.

Since 1966, the AV fistula was surgically created in an operating room

by sewing a major vein and artery together in the arm. When this is

done, blood from the artery will pass through the vein increasing its

flow rate and diameter. This makes the vein suitable for the insertion

of needles required for hemodialysis treatment. The AVF is the best

method for vascular access reducing hospitalization and mortality with

the additional benefits of longer term patency, improved flow rates and

fewer complications than other methods of vascular access.

No stranger to the groundbreaking technology, Drs. Cooper, Waheed and

the SKI Vascular Center were one of the participating sites in the US

Pivotal Trial for Ellipsys and are now the first site in the state of

Arizona (and first Ambulatory Surgical Center in the nation) to perform

Ellipsys procedures, post-FDA approval. In total, the SKI team have

treated over 40 patients with the technology leading up to FDA approval.

“It is rewarding to be able to offer a simpler, more efficient and

less-invasive option for patients requiring vascular access,” said Dr.

Cooper, who is also a Clinical Assistant Professor at the University of

Arizona. “We’re proud to have been a site in the clinical trial and to

be the first ASC in the country to provide this now FDA approved quality

of life improvement opportunity for ESRD patients. With no incision,

quicker recovery time, and the general simplicity of the fistula

creation, this procedure is so much easier on the patient. Just

yesterday we successfully performed three cases, and we look forward to

many more to come.”

“We’ve been very optimistic about this technique and technology since we

completed the pivotal trial,” said Dr. Waheed, who is also the managing

partner for the SKI Vascular Centers. “Now we’ve had a chance to follow

those patients since the trial concluded three years ago and have seen

first hand that they require significantly less maintenance procedures

to maintain their fistulas. In addition, many patients have been

requesting a percutaneous AVF since the end of the clinical trial and

were unable to get one prior to FDA approval. Now that Ellipsys is FDA

approved, we’re excited to finally be able to start offering patients

this minimally invasive procedure again.”

SKI Vascular Center is part of the Southwest Kidney Institute, an

interconnected network of 47 offices and 70 providers in Arizona. Its

staff of highly trained professionals offers an array of the most

technologically advanced procedures for the prevention and treatment

of dialysis access-related complications and various vascular diseases.

Media: To arrange an interview with Dr. Cooper or patient success

stories, or to receive more information about the new Ellipsys Vascular

Access System, please contact Paul Williams at 310/569-0023 or paul@medialinecommunications.com.

Contacts

Paul Williams, 310/569-0023