J&J launches ETHICON 4000 Stapler for secure surgical experience

Johnson & Johnson MedTech, a global leader in surgical technologies and solutions, today announced the U.S. launch of the ETHICON™ 4000 Stapler, an advanced surgical stapler designed to manage tissue complexities and deliver exceptional staple line integrity to minimize risk factors for surgical leaks and bleeding complications across 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.

“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.”

Addressing surgical complications across specialties
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.

“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.”

Surgical stapling technology backed by real-world evidence
Since 2017, the use of ETHICON™ Surgical Stapling devices has demonstrated an association with improved clinical and economic outcomes—across varied tissue types, patient populations and countries—in bariatric, thoracic, and colorectal procedures.

The ETHICON 4000 Stapler and ETHICON 3D Reloads build on this expertise to deliver staples with offset closure of the staple legs to more evenly distribute compression throughout the staple line, improving staple line integrity, leak resistance, and hemostasis. The redesigned stapler reload continues to feature enhanced Gripping Surface Technology (GST) that has been optimized to stabilize tissue and reduce tissue slippage. The new ETHICON advanced stapling technology, including the end-effector and reloads, are designed for future use exclusively on the OTTAVA Robotic Surgical System.

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