Ethicon Launches ECHELON FLEX™ GST System With Advanced Gripping Surface Technology

The Next Evolution in Staplers Offers the Least Tissue Slippage during Firing

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Oct 27, 2014, 04:15 ET

SAN FRANCISCO, Oct. 27, 2014 /PRNewswire/ -- Ethicon* announced today the launch of the ECHELON FLEX GST SYSTEM, a new powered stapler and reload system uniquely designed to provide a better grip on tissue for the least tissue slippage during firing.¹The device will be featured at The American College of Surgeons Clinical Conference in San Francisco this week.

Tissue movement or slippage during firing can result in poorly formed and spaced staples as well as the need for extra firings to complete the intended tissue transection. Through proprietary Gripping Surface Technology (GST), the ECHELON FLEX GST System provides a more secure hold on tissue² to deliver four times less tissue slippage for more targeted tissue transections³ and the potential to eliminate one reload per procedure^{1 __}which may provide enhanced economic value. Less tissue slippage during firing also results in consistent staple formation across a range of tissue thicknesses with each reload.

"Surgeons have long needed a stapling solution that enables reliable performance and staple line security without potential risk of additional tissue trauma, particularly in bariatric surgery procedures such as sleeve gastrectomy, where they may encounter an unexpected variance in tissue thickness," said Dr. Elliott Fegelman, Senior Medical Director at Ethicon. "The exciting aspect of the ECHELON FLEX GST System is that you now have optimal compression integrated with better grasping during the firing sequence. This means consistent staple formation, which may help reduce the risk of a leak or bleeding across broad range tissue thicknesses thereby reducing the potential for complications."

The ECHELON FLEX GST System is the latest offering in Ethicon's ECHELON FLEX Line of Powered Endocutters. Built on the stability of a powered firing, the system provides 88% less movement at the end effector⁴ and potentially less trauma to adjacent tissue.

The ECHELON FLEX GST System includes the ECHELON FLEX™ Powered Plus Stapler and the ENDOPATH ECHELON™ Reloads with Gripping Surface Technology. Designed for bariatric, colorectal and thoracic procedures, the ECHELON FLEX GST System is now available to customers in the U.S. and will be introduced globally beginning in the first quarter of 2015.

Benefits of the ECHELON FLEX GST SYSTEM include:

4x less tissue slippage during firing compared to Endo GIA™ Reloads with Tri-Staple™ technology for unsurpassed staple performance³
- May eliminate 1 reload per procedure¹ due to less tissue slippage during firing
- Delivers a more targeted tissue transection with each firing⁵
Only system that provides uniform closed staple height for exceptional staple line integrity now across a range of tissue thicknesses with each reload
Exclusive reloads with Gripping Surface Technology, offering a proprietary ridged surface to provide an atraumatic grip that holds tissue in place during firing.⁶

Learn more about the ECHELON FLEX GST System at www.ethicon.com/gst.

About ECHELON FLEX™ Endocutters
ECHELON FLEX™ Endocutters are used in more procedures than all other brands. More U.S. surgeons use Ethicon Endocutters than any other endocutter (IMS market share data 1/08-11/13 of U.S. endocutter codes sold units). The new ECHELON FLEX GST System builds upon the existing performance and benefits of the proven ECHELON FLEX™ Platform: the stability of a powered firing; uniform compression with 3-point gap control; great articulation angle to help access transection sites that are difficult to reach; and the ability to grasp, hold and manipulate tissue without the use of a second device.

About Ethicon
Ethicon, Inc. and Ethicon Endo-Surgery, Inc., two companies with long histories of medical innovation, do business under the Ethicon brand. Their surgical technologies and products (including sutures, staplers, energy devices, clip appliers, trocars and meshes) are used around the world to treat colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. Ethicon, Inc. and Ethicon Endo-Surgery, Inc. are part of the Johnson & Johnson Family of Companies. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

*Ethicon represents the products and services of Ethicon, Inc. and Ethicon Endo-Surgery, Inc. which are marketed and distributed by Ethicon US, LLC.

The third party trademarks used herein are trademarks of their respective owners.

FOOTNOTES
¹Benchtop 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).

²Benchtop testing in porcine stomach tissue. Mean peak load required to pull tissue from the clamped jaws of 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 (GST60B 6.496lbf & GST60T 7.789lbf vs EGIA60AMT 1.325lbf & EGIA60AXT 1.920lbf, all p<0.001).

³Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing ECHELON FLEXª Powered Plus Stapler (PSEE60A) and ECHELON Reload with GST vs ENDO GIA™ ULTRA Handle (EGIAUSTND) and Endo GIA™ Reload with Tri-Staple™ Technology at 3.3 and 4.0mm tissue thicknesses (3.3mm: GST60T 0.642mm vs EGIA60AMT 4.806mm p<0.001; 4.0mm: GST60T 0.654mm vs EGIA60AXT 5.116mm p<0.001).

⁴Benchtop testing on porcine stomach tissue. Surgeons (n=19) fired each instrument/ reload once: PSE60A/ ECR60G, 030449/ 030459, and EGIAUSTND/ EGIA60AMT. Distal tip motion measurement during the firing cycle showed a median of 88% and a range of reduction of 71% to 95% in tip movement of PSE60A/ ECR60G vs. the other two devices.

⁵Benchtop testing in porcine stomach tissue. Mean tissue movement from before clamping on tissue to release of tissue 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 2.835mm vs EGIA60AMT 2.369mm NS; 2.5mm: GST60G 2.864mm vs EGIA60AMT 3.273mm p<0.001; 3.3mm: GST60T 0.897mm vs EGIA60AMT 6.814mm p<0.001; 4.0mm: GST60T 1.415mm vs EGIA60AXT 4.616mm p<0.001).

⁶Based on 10-15 second clamp and release testing on animate preclinical lung and vasculature. Visual comparisons of 40 paired clampings immediately following, and at 1hr after clamping.

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding expectations for the ECHELON FLEX GST System. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon, Inc., Ethicon Endo-Surgery, Inc., Ethicon US, LLC, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: manufacturing difficulties and delays, internally or within the supply chain; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to laws and regulations and domestic and foreign health care reforms; and general industry conditions, including trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Ethicon companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.)

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SOURCE Ethicon