Johnson & Johnson has secured European CE Mark approval for its ETHICON 4000 Stapler, a new-generation surgical device designed to improve staple line reliability across a broad range of tissue thicknesses.
Built with proprietary 3D Stapling Technology, a redesigned end-effector, and streamlined reload system, the ETHICON 4000 Stapler and ETHICON 3D Reloads are now approved for use in both open and laparoscopic surgeries across the European Union. The technology is also being positioned for future integration with the OTTAVA Robotic Surgical System.
“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 company says the new stapling platform is designed to address a persistent surgical challenge: variability in tissue thickness, which can compromise staple line integrity and lead to complications. Surgeons frequently reinforce staple lines in practice, with one cited study reporting reinforcement in 77% of laparoscopic sleeve gastrectomy procedures.
The stakes extend beyond the operating room. Johnson & Johnson highlighted data showing that complications such as leaks and bleeding can carry significant financial burden for healthcare systems.
In the UK, prolonged air leaks have been linked to 27% of thoracic surgery patients, adding an average of €5,200 per case over a 90-day postoperative period. A separate Swiss study found bleeding events in 8% of thoracic surgeries, with additional costs exceeding €26,000 per case.
The company pointed to real-world evidence since 2017 suggesting its surgical stapling portfolio has been associated with improved clinical and economic outcomes across bariatric, thoracic, and colorectal procedures.
The OTTAVA Robotic Surgical System remains under development and is not yet cleared for commercial use in any market.
