Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, has announced the U.S. launch of the ETHICON™ 4000 Stapler—an advanced surgical device engineered to address tissue complexities and ensure superior staple line integrity, helping reduce the risk of surgical leaks and bleeding across multiple specialties.
With proprietary 3D Staple Technology, a redesigned end effector, and streamlined reload options for consistency from the first staple to the last to reduce potential leak pathways, the ETHICON™ 4000 and ETHICON™ 3D Reloads are approved for use in open and laparoscopic surgery today. The new advanced stapling technology and reloads are also planned for future use exclusively on the OTTAVA™ Robotic Surgical System. The company will showcase the ETHICON 4000 System alongside its comprehensive portfolio of surgical technologies at the American Society for Metabolic and Bariatric Surgery Annual Meeting taking place in Washington, DC, on June 15-19, 2025.
“We are building on a legacy of innovation and trusted performance in surgical instrumentation to offer new innovations that address some of the most common and costly surgical complications,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “As surgeons work diligently to meet the changing needs of patients, surgical technology must adapt. Johnson & Johnson MedTech is responding by delivering innovation for consistent and reliable experiences across open, minimally invasive, and robotic surgery.”
When stapling is used during surgery to compress and fuse tissue together, thick, fragile, and inconsistent tissue create complex variables that can compromise the integrity of the staple line, which may result in leaks or bleeds. Complications in priority procedures are estimated to be nearly $3B in cost burden in the U.S. alone. About half of bariatric surgeons report taking extra steps to reduce complications from leaks and bleeding at the staple line, including using adjunctive hemostasis products, placing clips, or oversewing.
The ETHICON 4000 Stapler with ETHICON 3D Reloads elevates stapler performance to address common complications and reduced staple line interventions due to bleeding by 23% compared to traditional 2D staples.
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“The 3D Stapling Technology allows me to more evenly distribute pressure throughout the staple line with more consistency,” said, Kelvin D. Higa, MD, FACS, FASMBS, FIFSO, Clinical Professor of Surgery at the UCSF Fresno Medical Education Program, and VP, Chief Medical and Quality Officer at Fresno Heart and Surgical Hospital. “As a surgeon, these technological advancements featured on the ETHICON 4000 will give me greater peace of mind when navigating tissue complexities, even in my most complicated procedures. As Chief Medical and Quality Officer, it is essential we evaluate all devices in the context of safety and value for our organization.”