SKI Vascular Center is First Ambulatory Surgical Center in the Nation to Utilize FDA-Approved Ellipsys System for Non-Surgica...
December 06 2018 - 12:30PM
Business Wire
Local Interventional Nephrologists Randy Cooper, M.D. and Umar
Waheed, M.D., Pioneer Breakthrough Endovascular Arteriovenous
Fistula (endoAVF®) Technology for ESRD Patients
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.
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Paul Williams, 310/569-0023paul@medialinecommunications.com