Ethicon Expands Bariatric Surgery Portfolio; Unveils “Evidence Corner” At IFSO To Address Obesity And Metabolic Diseases
Highlights New Stapler System and Advanced Energy Devices, and Provides Forum for New Evidence Generation
MONTREAL, QUEBEC - CANADA – Aug. 26, 2014 – Ethicon* is introducing three new endocutter and energy products designed to help address the unique challenges of bariatric procedures such as sleeve gastrectomy and gastric bypass.
The announcement was made today at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014), where Ethicon is featuring 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 with a 7 mm vessel sealing indication.
“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 science-based portfolio for obesity and metabolic diseases 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, Ethicon Group Chairman. “In addition, we remain committed to supporting long-term research that contributes to a greater understanding of the value and role of metabolic and bariatric surgery in treating obesity and related metabolic diseases worldwide.”
Ethicon is also launching the “Evidence Corner” at IFSO 2014 (Booth 501) to drive greater industry focus on the global health and economic challenges of obesity and metabolic diseases. The goal is to provide a forum for the exchange of ideas aimed at generating new evidence and insights that can lead to new treatments for obesity and its associated diseases, and improve access to care for patients worldwide. Surgeons and healthcare professionals can meet with Ethicon’s clinical and health economics teams to learn about current research studies funded by Ethicon and submit their own ideas for future studies.
ECHELON FLEX™ GST SYSTEM – Less Tissue Slippage for Unsurpassed
Tissue slippage during firing may cause poor staple formation and lead to leakage, bleeding or “tissue milking” out of the end of the device, requiring clinical intervention and additional reloads. The ECHELON FLEX™ GST System, which includes the ECHELON FLEX Powered Plus Stapler and the ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST), is designed to address these clinical issues through its unique design for better grip that provides less tissue slippage.[i] In testing, the ECHELON FLEX GST System resulted in 4-times less tissue slippage during firing compared to Covidien’s ENDO GIA™ Reloads with TriStaple™ technology,[ii] which may eliminate one reload per procedure.i Less tissue slippage during firing may provide reliable staple formation across a range of tissue thicknesses with each reload. Built upon the benefit of stability with a powered firing, the ECHELON FLEX™ GST System provides the least tissue slippage for the least movement during firing.i Ethicon will launch the ECHELON FLEX™ GST System in the United States and Europe later in the year.
ENSEAL® G2 Articulating Tissue Sealer – Changing the Way Bariatric Surgeons Access Tissue
The 45cm length of the ENSEAL® G2 Articulating Tissue Sealer for bariatric surgery is set to launch globally later in 2014. This advanced bipolar energy device is the only such device designed to enable a perpendicular approach to cutting and sealing vessels up to seven millimeters in diameter, and lymphatics, through a 5mm port. Vessels sealed with a perpendicular approach are more than 28% stronger than vessels sealed at a 45 degree angle.VI 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 spaces.i The ENSEAL® G2 Articulating Tissue Sealer increases the ability to take the full vessel in a single bite.
HARMONIC ACE®+7 Shears – Precise Ultrasonic Sealing of Larger Vessels ;
The HARMONIC ACE®+7, available in 36cm and 45cm for bariatric surgery, is the only purely ultrasonic energy device with a 7mm vessel sealing indication. The device has greater 5mm to 7mm vessel-sealing reliability than Covidien’s LigaSure™ devices when in the Advanced Hemostasis Mode[iii]:
- 140% higher median burst pressure than LigaSure™ 5mm Blunt Tip[iv]
- 112% higher median burst pressure than LigaSure Advance™[v]
“This ultrasonic vessel-sealing device is an advance for taking down larger vessels,” said bariatric surgeon Robin Blackstone, MD, 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.
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.
Dr. Robin Blackstone is a paid consultant for Ethicon
*Ethicon represents the products and services of Ethicon, Inc. and Ethicon Endo-Surgery, Inc.
The third party trademarks used herein are trademarks of their respective owners.
i 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).
[ii] 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 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).
[iii] In benchtop test on 5‐7mm porcine carotids that compared burst pressure failures under 240 mmHg, HARMONIC ACE®+7 (2/152 failures) versus LigaSure™ 5mm Blunt Tip and LigaSure™ Advance (15/154 failures) (P = 0.001) Data on file (PRC064872).
[iv] In benchtop test using 5‐7mm porcine carotids that compared median burst pressure for HARMONIC ACE®+7 (1419 mmHg) and LigaSure™ 5mm Blunt Tip (591 mmHg) (p< 0.001). Data on file (PRC064872).
[v] In benchtop test using 5‐7mm porcine carotids that compared median burst pressure for HARMONIC ACE®+7 (1419 mmHg) and LigaSure™ Advance (670 mmHg) (p< 0.001). Data on file (PRC064872).
VI ENSEAL® devices tested in a benchtop study on 5-7mm porcine carotid arteries. With NSLG2C35A devices, median burst pressures were 51% higher for vessels sealed at a 90° angle compared to vessels sealed at a 45° angle (p=0.0007). With NSLG2S35A devices, mean burst pressures were 29% higher for vessels sealed at a 90° angle compared to vessels sealed at a 45° angle (p=0.001).
(This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon Endo-Surgery, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, the satisfaction of closing conditions for the acquisition, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act and certain customary closing conditions; the possibility that the transaction will not be completed; general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward healthcare cost containment; and increased scrutiny of the healthcare industry by government agencies. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to the ability of Ethicon Endo-Surgery, Inc. and Johnson & Johnson to successfully integrate the business, products and employees of SterilMed, Inc., as well as the ability to ensure continued performance or market growth of SterilMed, Inc.’s business and products. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ethicon Endo-Surgery, Inc. nor Johnson & Johnson undertakes to update any forward-looking statements as a result of new information or future events or developments.)