TERUMO® Launches Expanded GLIDEWAY™ Access Sheath Portfolio With A New Product For Minimally Invasive Urologic Procedures

TERUMO® Launches Expanded GLIDEWAY™ Access Sheath Portfolio With A New Product
                  For Minimally Invasive Urologic Procedures

New GLIDEWAY™ Ureteral Access Sheath Offers Advanced Features Designed to
Minimize Trauma

PR Newswire

SOMERSET, N.J., May 15, 2014

SOMERSET, N.J., May 15, 2014 /PRNewswire/ -- TERUMO, a leading global medical
device company, today announced the U.S. launch of its new GLIDEWAY™ Ureteral
Access Sheath. It is the latest addition to the GLIDEWAY™ Access Sheath
portfolio used in minimally invasive urologic procedures including
ureteroscopy and percutaneous nephrolithotomy  (PCNL). The sheaths will be
introduced at the 2014 American Urological Association (AUA) Annual Meeting,
in Orlando, Florida.

Conventional access sheaths currently used for urologic intervention have been
tied to complications and injury including perforation and significant
bleeding.^1,2 The new family of GLIDEWAY™ Access Sheaths has innovative and
refined features designed to minimize trauma while ensuring maximum and
efficient access:

  oURETEROSCOPY: GLIDEWAY™ Ureteral Access Sheath
    Precision linear tip design with ultra smooth transitions engineered to
    optimize day-to-day urologic access needs
  oURETEROSCOPY: GLIDEWAY™ Balloon-Expandable Ureteral Sheath
    Radially-expanding sheath with an integrated balloon designed to minimize
    sheath profile and friction during insertion
  oPCNL: GLIDEWAY™ Balloon-Expandable PCNL Sheath
    One-step insertion of balloon and radially-expanding sheath designed for
    easier insertion and reduced trauma

"GLIDEWAY Access Sheaths offer unique characteristics with the potential to
reduce urothelial trauma and simplify access into the kidney," said Duane
Baldwin, MD, Professor at Loma Linda University, and one of the primary
investigators in early studies of expanding sheath technologies. A study using
a one-step balloon-expandable PCNL sheath demonstrated successful access and
visualization in patients of different ages, body mass indexes, and renal
stone locations without instances of collecting system injuries.^3 Similarly,
an observational study demonstrated less insertion force and less urothelial
tear length with a radially-dilating ureteral access sheath as compared to
conventional sheaths.^4

"The GLIDEWAY Access Sheath portfolio launch is an important milestone for
TERUMO in advancing our urology interventional platform," said Chris Pearson,
Vice President of Marketing, Terumo Interventional Systems. "It builds on our
proven performance in urologic access with the GLIDEWIRE® Hydrophilic
Guidewire and demonstrates our commitment to the urology space. In partnership
with healthcare providers, TERUMO will continue to apply our global resources,
industry leading innovation and world class manufacturing to accomplish our
mission of Contributing to Society Through Healthcare."

For more information about the GLIDEWAY™ Access Sheaths, visit
www.terumois.com/glideway

About Ureteroscopy and PCNL Procedures
Ureteroscopy and PCNL are current standards of care for minimally-invasive
urologic intervention especially for stone management in the urinary tract.
One in 11 people in the U.S. suffer from kidney stone disease and the
prevalence is growing driven by incidence of obesity and diabetes, which are
common risk factors for stone disease.^5 In 2013, more than 350,000
ureterosopy and PCNL procedures were performed in the U.S. and that number is
expected to grow consistently over the next decade with the need for less
invasive surgical procedures.^6

Terumo Corporation
TERUMO is a leading global medical device company with over $4 billion in
sales and operations in over 160 countries. TERUMO is committed to
establishing a strong leadership position in Urology through a platform of
innovation, world-class manufacturing, and a collaborative approach with
healthcare providers to meet today's medical challenges.

TERUMO is the manufacturer and exclusive U.S. distributor of GLIDEWIRE®
Urologic Hydrophilic-Coated Guidewires as well as GLIDEWAY™ Access Sheaths.

TERUMO combines world-class research and a deep market understanding to
deliver technology solutions and high-quality education programs that deliver
clinical value, economic benefit, and enhanced patient outcomes.

For more information, visit www.terumois.com.

1. Traxer O and Thomas A. Prospective evaluation and classification of
ureteral wall injuries resulting from insertion of a ureteral access sheath
during retrograde intrarenal surgery. J Urol. 2013 Feb;189:580-4.
2. Safak M, Gogus C, Soygur T. Nephrostomy tract dilation using a balloon
dilator in percutaneous renal surgery: Experience with 95 cases and comparison
with the fascial dilator system. Urologia Internationalis. 2003;71:382-4.
3. Baldwin DD, Maynes LJ, Desai PJ, Jellison FC, Tsai CK, Barker GR. A novel
single step percutaneous access sheath: The initial human experience. J Urol.
2006 Jan;175:156-61.
4. Harper JD, Ebrahimi KY, Auge BK, Lamberton GR, Pham AK, Zuppan C, Albala
DM, Preminger GM, and Baldwin DD. Comparison of a novel radially dilating
balloon ureteral access sheath to a conventional sheath in the porcine model.
J Urol. 2008 May;179:2042-5.
5. Scales CD, Smith AC, Hanley JM, Saigal CS. Urologic diseases in America
project. Prevalence of kidney stones in the United States. Euro Urol.
2012;62:160-5.
6. Millennium Research Group. US Markets for Urological Devices 2014.

SOURCE Terumo Medical Corporation

Website: http://www.terumois.com
Contact: Rosemarie Mendes, Sr. Marketing Communications Manager, Terumo
Interventional Systems, (t) 732.575.0817, (e)
rosemarie.mendes@terumomedical.com
 
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