Johnson & Johnson MedTech launches the ETHICON 4000 Stapler

Johnson & Johnson MedTech has launched the ETHICON 4000 Stapler, an advanced surgical stapler designed to manage tissue complexities and deliver exceptional staple line integrity to minimise risk factors for surgical leaks and bleeding complications across specialties, in the US.

ETHICON 4000 Stapler

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. The new advanced stapling technology and reloads are also planned for future use exclusively on the OTTAVA Robotic Surgical System.

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 US alone. About half of bariatric surgeons report taking extra steps to reduce complications from leaks and bleeding at the staple line, including using adjunctive haemostasis products, placing clips or oversewing. 

“The 3D Stapling Technology allows me to more evenly distribute pressure throughout the staple line with more consistency,” said Dr Kelvin D Higa, 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 organisation.”  

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.

“When I am performing surgery, potential complications related to tissue variability are top of mind,” said Dr Erik Wilson, Chief of Minimally Invasive and Elective General Surgery UT Health Houston. “Consistency and reliability of performance across open, laparoscopic, and robotic surgery could address a significant unmet need in today’s OR.”

Since 2017, the company claims 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 stabilise 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. 

“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.” 

The ETHICON 4000 Stapler and ETHICON™ 3D Reloads, 60mm, received 510(k) clearance by the UFDA earlier this year. The ETHICON 4000 Stapler and ETHICON 3D Reloads will soon be commercially available in the US with availability to select hospital sites in select markets forthcoming.  

The OTTAVA Robotic Surgical System is under development and is not authorized to be marketed or sold in any market.