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

SOMERSET, NJ (May 15, 2014)--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:

• URETEROSCOPY: GLIDEWAY™ Ureteral Access Sheath

  Precision linear tip design with ultra smooth transitions engineered to optimize day-to-day urologic access needs

• URETEROSCOPY: GLIDEWAY™ Balloon-Expandable Ureteral Sheath

  Radially-expanding sheath with an integrated balloon designed to minimize sheath profile and friction during insertion

• PCNL: GLIDEWAY™ Balloon-Expandable PCNL Sheath

  One-step insertion of balloon and radially-expanding sheath designed for easier insertion and reduced trauma

Figure 1. GLIDEWAY™ Access Sheaths

"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."

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

Reference

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.