Johnson & Johnson MedTech launches Easy-To-Use Staple Line Reinforcement Device for Bariatric, Thoracic and General Surgery

New ECHELON ENDOPATH™ Staple Line Reinforcement offers significant improvements over existing buttressing solutions. 

TThe surgery portfolio from Johnson & Johnson MedTech, has launched the ECHELON ENDOPATH™ Staple Line Reinforcement (SLR), a buttressing device designed to further strengthen staple lines and reduce potential complications during bariatric, thoracic, and general surgical procedures.  This is the company’s first buttress solution designed for use with its own industry-leading ECHELON FLEX™ Powered Staplers, including the Echelon 3000, which have been associated with a lower rate of bleeding complications and air leaks.^1,2

The ECHELON ENDOPATH™ Staple Line Reinforcement has been designed to assist surgeons seeking enhanced strength around the staple line and to overcome the challenges posed by existing buttressing options, which can be difficult to load, provide inconsistent staple line coverage, and may loosen with typical manoeuvring in stapling procedures.

Designed for ease of use, the ECHELON ENDOPATH™ Staple Line Reinforcement allows a seamless buttress experience from start to finish.^3-5 The device was engineered with a simple click-and-go applicator to provide accurate placement on the stapler before firing^A,6 and makes applying the buttress easy for surgeons and OR staff.^{B, 7} 

The ECHELON ENDOPATH™ Staple Line Reinforcement also provides exceptional coverage after tissue manipulation. The buttress affixes across the entire anvil and cartridge face for no slipping, twisting, sliding, or bunching. This means the buttress stays reliably in place on the device, yet gently releases from tissue.^A,3-5,8 Benchtop studies showed that it achieved a more secure attachment throughout tissue manipulation than GORE^® SEAMGUARD^® Staple Line Reinforcement.^C,3-5

“The ECHELON ENDOPATH Staple Line Reinforcement is much easier to load compared to other reinforcement brands currently on the market and made the case finish succinctly. It was easier to use, and the staple line was more uniform and haemostatic,” said Mr P S Jambulingham, Upper GI & Bariatric Consultant Surgeon at Luton and Dunstable University Hospital NHS Trust.^D

“The launch of the ECHELON ENDOPATH Staple Line Reinforcement is a testament to our relentless pursuit of innovation in surgical technology," commented Sandy Phillips, Business Unit Director Endo Mechanical and Energy, at Johnson & Johnson MedTech UK. "By providing both enhanced stapling and advanced buttressing options, we aim to empower surgeons with the tools they need to achieve the best possible outcomes for their patients."  

About ECHELON ENDOPATH™ Staple Line Reinforcement  

ECHELON ENDOPATH™ Staple Line Reinforcement is a sterile, bioabsorbable staple line reinforcement. The applicator contains a set of reinforcement materials, one each for the upper and lower stapler jaws. The ECHELON ENDOPATH™ Staple Line Reinforcement contains a pre-applied, patterned adhesive composed of a mixture of water soluble alkylene oxide copolymers, which attaches the reinforcement material to the stapler reload and anvil.⁹  

ECHELON ENDOPATH™ Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH™ Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures.⁹

Footnotes:

i. In a benchtop test, ECHELON ENDOPATH™ Reinforcement covered all staple legs in (40/40) applications after tissue manipulation on porcine tissue during simulated surgical use, p<0.05. Based on benchtop testing and clinical effect is unknown.

ii. In a design validation with 17 nurses, 100% agreed that ECHELON ENDOPATH™ Staple Line Reinforcement is easy to load onto the endocutter.

iii. Following Coverage After Manipulation Assessment ECHELON ENDOPATH™ Reinforcement had no failed coverage. In a benchtop test, ECHELON ENDOPATH™ Staple Line Reinforcement covered all staple legs in (40/40) applications compared to GORE^® SEAMGUARD® (11/40) after tissue manipulation on porcine tissue during simulated surgical use, p<0.05. Based on benchtop testing and clinical effect is unknown.

iv. Mr P S Jambulingham has not been compensated for his testimonial.

References:

1. Miller DL, Roy S, Kassis ES, Yadalam S, Ramisetti S, Johnston SS. Impact of Powered and Tissue- Specific Endoscopic Stapling Technology on Clinical and Economic Outcomes of Video-Assisted Thoracic Surgery Lobectomy Procedures: A Retrospective, Observational Study. Adv Ther. 2018;35(5):707-723. doi:10.1007/s12325-018-0679-z
2. Eckert CE, Harris JL, Wong JB, et al. Preclinical quantification of air leaks in a physiologic lung model: effects of ventilation modality and staple design. Med Devices (Auckl). 2018;11:433-442. Published 2018 Dec 14. doi:10.2147/MDER.S184851
3. Ethicon Project Zeppelin Coverage after Manipulation Comparison Completion Report, A.1. 01/28/2019. Windchill Document #PRC086040 (EM_ETH_STAP_301624, EM_ETH_STAP_301548, EM_ETH_STAP_302814)
4. Ethicon, Zeppelin Echelon Buttress Test Methods, P.4. 09/27/2022. Windchill Document #SCN042153 (EM_ETH_STAP_301624, EM_ETH_STAP_301548, EM_ETH_STAP_302814)
5. Ethicon Zeppelin Claim Testing Memo, A.1. 03/19/2019. Windchill Document #SCN063382 (EM_ETH_STAP_301624, EM_ETH_STAP_301548, EM_ETH_STAP_302814)
6. Ethicon Zeppelin Requirements Management Quality Record, N.2. 10/25/2022. Windchill Document # DR000338 (EM_ETH_STAP_302082)
7. Ethicon Project Zeppelin Nurse Design Validation Completion Report, A.1. 06/15/2020. Windchill Document #PRC089156 (EM_ETH_STAP_302229.1)
8. Ethicon, Final Report: Evaluation of the Tissue Healing Response Following Use of the EB3 Zeppelin Echelon Reinforcement Material Device for Laparoscopic Gastric, D.3 Windchill Document #PSP006552 (EM_ETH_STAP_301548)
9. Ethicon, ETHICON ECHELON ENDOPATH™ Staple Line Reinforcement IFU. 10.31.2022.