J&J gains CE Mark Approval for ETHICON 4000 Stapler

Johnson & Johnson has received European CE Mark approval for its new ETHICON 4000 Stapler, an advanced surgical stapler designed to deliver reliable staple line integrity across a wide range of tissue thickness.

ETHICON 4000 Stapler

With proprietary 3D Stapling Technology, a redesigned end-effector and streamlined reload options, the ETHICON 4000 and ETHICON 3D Reloads are certified for use in open and laparoscopic surgery across the European Union. The new advanced stapling technology and reloads are also planned for future use on the OTTAVA Robotic Surgical System.

Thick, fragile and inconsistent tissue present complex variables that can compromise staple line integrity and consequently, patient outcomes. As a result, surgeons are routinely intervening to mitigate complications, with one study finding that bariatric surgeons reinforced the staple line through oversew, buttress or a combination of both, in 77% of laparoscopic sleeve gastrectomy cases¹.

ETHICON 4000 advanced surgical stapler features ETHICON 3D Reloads with proprietary 3D Stapling Technology and enhanced Gripping Surface Technology to manage various tissues across specialties, including bariatric, colorectal and thoracic surgeries. Incorporating 3D stapling technology, the stapler is designed to optimise compression not only underneath each staple but also across staples and multiple staple lines, including both stapled and unstapled regions of the tissue.

“Surgical complications, including leaks and bleeding events, can impact surgical outcomes, causing distress to both patients and surgeons, and are associated with significant cost implications,” said François Gaudemet, President, Surgery EMEA, MedTech, Johnson & Johnson. “We are building on a long legacy of supporting surgeons and driving innovation for consistent and reliable experiences across open, minimally invasive and robotic surgery.”

The OTTAVA Robotic Surgical System is under development and is not authorised to be marketed or sold in any market, CE marking is pending.

References

1.      Zafar SN, Felton J, Miller K, Wise ES, Kligman M. Staple Line Treatment and Bleeding After Laparoscopic Sleeve Gastrectomy. JSLS. 2018 Oct-Dec;22(4):e2018.00056. doi: 10.4293/JSLS.2018.00056. PMID: 30607100; PMCID: PMC6305063.