Medical devices: bariatric surgery portfolio

Montreal, Quebec - Canada – Ethicon officials introduced 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 at the 19th World Congress of International Federation for the Surgery of Obesity & Metabolic Disorders (IFSO 2014), where Ethicon featured 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 also launched the “Evidence Corner” at IFSO 2014, working 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
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
The 45cm length of the ENSEALG2 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° 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
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]

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.

Source: Ethicon Inc. and Ethicon Endo-Surgery Inc. 

^{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 (670mmHg) (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).}