CE-Marked Stapler Designed to Improve Staple Line Integrity

Leaks and bleeding around stapled transections remain key drivers of morbidity and reintervention in gastrointestinal and thoracic surgery, prompting surgeons to reinforce staple lines to mitigate risk. Variability in tissue thickness and tissue fragility further challenges staple formation and hemostasis in both open and laparoscopic procedures. A new device now offers a CE‑marked option intended to provide reliable staple line integrity across a broad range of tissue thicknesses.

Johnson & Johnson has received European CE Mark approval for the ETHICON 4000 Stapler, which is certified for use across surgical specialties in the European Union. The system is designed to deliver reliable staple line integrity across varying tissue thicknesses in bariatric, colorectal, and thoracic procedures. The stapler pairs with ETHICON 3D Reloads and features a redesigned end‑effector with streamlined reload options.

The stapling platform employs proprietary 3D Stapling Technology that is designed to optimize compression beneath each staple and across staples and multiple staple lines, including both stapled and unstapled tissue regions. Enhanced Gripping Surface Technology is intended to help manage thick, fragile, and inconsistent tissue to support consistent staple formation. Together, these elements are aimed at promoting staple line integrity when tissue characteristics vary within a transection.

CE Mark approval certifies the ETHICON 4000 Stapler and ETHICON 3D Reloads for use in open and laparoscopic surgery throughout the European Union. The company reports that since 2017, use of its surgical stapling devices has been associated with improved clinical and economic outcomes across bariatric, thoracic, and colorectal procedures in real‑world settings. The new stapling technology and reloads are also planned to be harnessed for future use on the OTTAVA Robotic Surgical System, which remains under development and is not authorized to be marketed or sold in any market, with CE marking pending.

“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.”