Ethicon Expands Successful Bariatric Surgery Portfolio to Help Address Obesity and Metabolic Diseases

ECHELON FLEX GST System, ENSEAL® G2 Articulating Tissue Sealer and HARMONIC ACE®+7 Shears create a commanding tool kit for the challenges of bariatric surgery

HARMONIC ACE+7 Shears (Photo: Business Wire)

BOSTON--()--Three new Ethicon* innovations that meet the unique challenges of bariatric procedures will be presented to the global bariatric community this week. These surgical devices represent an expanded portfolio of solutions for surgeons performing procedures such as sleeve gastrectomy and gastric bypass, by providing stronger stapling in thick tissue, improved sealing performance and better access to vessels.

These latest Ethicon innovations include the new ECHELON FLEX GST System and a new 45cm ENSEAL® G2 Articulating Tissue Sealer alongside the HARMONIC ACE®+7 Shears with Advanced Hemostasis, the first purely ultrasonic device indicated for use for sealing large vessels up to 7mm. Ethicon will showcase the newest additions to its portfolio of bariatric solutions at Obesity Week, the preeminent international event of the American Society for Metabolic and Bariatric Surgery and The Obesity Society held November 2-7, 2014 in Boston.

“Ethicon, as part of the largest healthcare company in the world, is committed to leading the way to address the burden of obesity for patients and healthcare systems. Our portfolio of science-based solutions for obesity and metabolic disease is among the most comprehensive in the industry, and we continue to bring forward innovations that fill clinical needs and advance patient care,” said Michael del Prado, Company Group Chairman, Ethicon. “We are also committed to long-term research that contributes to a greater understanding of the value and role of metabolic and bariatric surgery as a life-changing intervention for treating obesity and related metabolic diseases worldwide. From introducing the first sterile sutures a century ago to our leadership in minimally invasive surgery, Ethicon is at the forefront of pushing the boundaries of surgery and shaping its future to improve and save lives.”

ECHELON FLEXGST SYSTEM – Less Tissue Slippage for Unsurpassed Stapling Performance

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 better grip on tissue2 to deliver four times less tissue slippage3 for more targeted tissue transections4 and the potential to eliminate one reload per procedure1 — which may provide enhanced economic value. Less tissue slippage during firing also results in reliable staple formation across a range of tissue thicknesses with each reload. 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.

HARMONIC ACE®+7 Shears – Precise and Reliable Ultrasonic Sealing

The HARMONIC ACE®+7, available in 36cm and 45cm for bariatric surgery, is the most intelligent and advanced HARMONIC® device ever introduced5. It is the only purely ultrasonic energy device with a 7mm vessel sealing indication. HARMONIC ACE®+7 is designed to reduce the number of surgical devices needed to achieve hemostasis, such as clip appliers, endoscopic linear cutters, reloads, sutures and other energy devices.

“This ultrasonic vessel-sealing device is an advance for strong and reliable vessel sealing,” said bariatric surgeon Robin Blackstone, M.D., Medical Director, Scottsdale Health Care Bariatric Center in Arizona**. “It provides advanced hemostasis and precise dissection, while generating less heat. This should translate into even better outcomes for bariatric surgery patients.”

In addition to bariatric surgery, the HARMONIC ACE®+7 may be used in a wide range of procedures and specialties, including General, Colorectal, Bariatric, Gynecology, Thoracic and Urology.

ENSEAL® G2 Articulating Tissue Sealer – Controlled Access Angle for Stronger Sealing in Bariatric Surgery

The 45cm length of the ENSEAL® G2 Articulating Tissue Sealer for bariatric surgery launched globally, recently in 2014. This advanced bipolar energy device is the only such device that is designed to enable a perpendicular approach to cutting and sealing vessels up to seven millimeters in diameter through a 5mm port. The device contributes to stronger seals when compared to ENSEAL® non-articulating devices. Also, because the device can bend and provide greater control over the angle of approach, it makes it easier for surgeons to access difficult-to-reach parts of the anatomy and provides better access to tissue in deep or tight spaces6. The ENSEAL® G2 Articulating Tissue Sealer increases the ability to take the full vessel in a single bite.

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.

**Dr. Robin Blackstone is a paid consultant for Ethicon.

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

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding expectations for the certain products. 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.)

FOOTNOTES

1 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).

2 Benchtop testing in porcine stomach tissue. Mean peak load required to pull tissue from the clamped jaws of ECHELON FLEX® Powered Plus and ECHELON Reload with GST vs ENDO GIA™ ULTRA and Endo GIA™ Reload with Tri-Staple Technology (GST60B 6.496lbf & GST60T 7.789lbf vs EGIA60AMT 1.325 & EGIA60AXT 1.920lbf, all p<0.001).

3 Benchtop testing in porcine stomach tissue. Mean tissue movement from after clamping on tissue to after firing 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). Benchtop 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).

4 Benchtop 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).

5 As compared to previously-introduced HARMONIC devices without Adaptive Tissue Technology and Advanced Hemostasis mode.

6 Compared to a non‐articulating device. Based on a benchtop burst pressure study. PRC051608

Contacts

Ethicon
Michelle Parker, 513-337-3590
mparker5@its.jnj.com
Ann Leibson, 513-337-8180
aleibson@its.jnj.com

Release Summary

Ethicon Expands Successful Bariatric Surgery Portfolio to Help Address Obesity and Metabolic Diseases Includes ECHELON FLEX GST System, ENSEAL G2 Articulating Tissue Sealer & HARMONIC ACE+7 Shears

Contacts

Ethicon
Michelle Parker, 513-337-3590
mparker5@its.jnj.com
Ann Leibson, 513-337-8180
aleibson@its.jnj.com