Healthcare products company Johnson & Johnson (NYSE:JNJ) announced on Wednesday that it has received European CE Mark approval for the ETHICON 4000 Stapler, designed to deliver consistent staple line integrity across varying tissue thickness in open and laparoscopic procedures.

Certified for use across the European Union, the device incorporates proprietary 3D Stapling Technology and ETHICON 3D Reloads to support multiple surgical specialties, including bariatric, colorectal, and thoracic surgery.

The technology is engineered to optimise tissue compression across and between staple lines, addressing challenges associated with thick, fragile, or inconsistent tissue that can impact surgical outcomes. Complications such as leaks and bleeding remain a significant cost driver, with studies citing prolonged air leaks in 27% of thoracic cases in the UK and bleeding events affecting 8% of cases in Switzerland.

Johnson & Johnson said that its advanced stapling platform is supported by real-world evidence since 2017, demonstrating improved clinical and economic outcomes across procedures and patient populations.

The company also plans to integrate the technology into its OTTAVA Robotic Surgical System, which remains under development and is not yet authorised for commercial use.