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Devices Surgery Product Launch

 News Release - May 5, 2017

New ECHELON FLEX(TM) GST System (45mm) Delivers Benefits of Precision Stapling Performance to Thoracic and Colorectal Procedures

CINCINNATI, May 5, 2017 -- (Healthcare Sales & Marketing Network) -- Ethicon * announced today the U.S. launch of the ECHELON FLEX™ GST (Gripping Surface Technology) 45mm Systemi, designed to control tissue movement in thoracic and colorectal surgery and enable surgeons to transect as they intend, even in the most challenging tissue conditions. The ECHELON FLEX™ GST System, available in two lengths, 60mm and now 45mm, was featured this week at the American Association for Thoracic Surgery (AATS) Annual Meeting in Boston, MA.

With the addition of the 45mm endocutter, the ECHELON FLEX™ GST System now provides a complete offering that addresses the unique challenges of thoracic and colorectal procedures involving diseased, thick and thin tissue. The ECHELON FLEX™ GST System is uniquely designed to enable precision stapling performance with exceptional staple line integrity across the broadest range of tissue thicknessii, and is ideally suited for thoracic, colorectal and bariatric surgery.

"The Echelon Powered Endocutter family has been shown in a very large retrospective study to be associated with significantly reduced hemostasis complications as well as total hospital costs," says Tom O'Brien, Vice President, Global Endomechanical Platform Leader at Ethicon. "The GST technology in this new device minimizes lateral tissue movement which may reduce mucosal bleeding and aids in the capture of all tissue layers, including the mucosa. Failure to capture the mucosa may disrupt the healing process, reduce transection site integrity and decrease staple line integrity."

Exceptional Stapling Precision for Optimal Outcomes

Designed for stability, the ECHELON FLEX™ GST System delivers less tissue slippage during firing by controlling tissue movement with pre-compression and Gripping Surface Technology, which is more likely to completely capture mucosa in the staple line versus the other leading endocutter on the market.iii Better mucosal capture improves staple line integrity and leak resistance, and provides optimal conditions for tissue healing.iii

The ECHELON FLEX™ GST System is efficient and cost effective and may eliminate one reload due to less tissue slippage during firingiv compared to ENDO GIA™ Reloads with Tri-Staple™ Technology. The system is associated with reduced procedural costs related to staple line interventions compared with standard reloadsv, with 42% fewer staple line interventionsvi and now offers a new black 45mm reload, intended for use in very thick tissue.

To learn more about the ECHELON FLEX™ GST System visit: http://www.ethicon.com/healthcare-professionals/products/staplers/endocutters/echelon-flex-gst-system.

About Ethicon

From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

* Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.

I System components include ECHELON FLEX™ Powered Plus Stapler and ENDOPATH ECHELON™ Reloads with Gripping Surface Technology.

ii ECHELON FLEX™ GST System designed and tested to accommodate a tissue thickness range of 1.0mm to 4.0mm (measured at 8g/mm2) vs the Medtronic Tri-Staple portfolio intended for a thickness range of 0.75mm to 3.0mm (per IFU & materials downloaded from Medtronic website on Nov 16,2016).

iii ECHELON FLEX™ GST System Blue and Green Reloads compared to Endo GIA™ with Tri Staple™ Technology Purple Reloads evaluated via gross observations of firings in 1.5mm to 3.0mm thick animate porcine ileum. Mucosal capture was rated via a 5-point Likert scale with the highest rating representing fully captured mucosa.

iv Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEX™ Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 1.5, 2.5, 3.3 and 4.0mm tissue thicknesses (1.5mm: GST60B 1.067mm vs EGIA60AMT 2.452mm p<0.001; 2.5mm: GST60G 1.148mm vs EGIA60AMT 3.261mm p<0.001; 3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001).

v Based on a Budget Impact Model utilizing Ethicon sponsored US clinical trial-reported data on intra-operative surgical interventions associated with GST vs standard reloads in laparoscopic sleeve gastrectomy and procedural costs inputs from published literature and US market intelligence.

vi Based on a prospective, multi-center study of staple line interventions required during transection of the greater curvature of the stomach in laparoscopic sleeve gastrectomy procedures, comparing the [ECHELON FLEX] GST System (mean # of interventions 1.1) to standard reloads (mean # of interventions 1.9). Evaluation of a Powered Stapler System with Gripping Surface Technology on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy. Fegelman E, Knippenberg S, Schwiers M, et al. Accepted for publication in J Laparoendosc Adv Surg Tech.


Source: Ethicon

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