Johnson & Johnson announced that it has received European CE Mark approval for its new ETHICON 4000 Stapler, an advanced surgical stapler designed to deliver reliable staple line integrity across a range of tissue thickness.
With proprietary 3D Stapling Technology, a redesigned end-effector and streamlined reload options, the ETHICON 4000 and ETHICON 3D Reloads are certified for use in open and laparoscopic surgery across the European Union. The new advanced stapling technology and reloads are also planned for future use on the OTTAVA Robotic Surgical System.
Addressing surgical complications across specialties
Thick, fragile and inconsistent tissue present complex variables that can compromise staple line integrity and consequently, patient outcomes. As a result, surgeons are routinely intervening to mitigate complications, with one study finding that bariatric surgeons reinforced the staple line through oversew, buttress or a combination of both, in 77% of laparoscopic sleeve gastrectomy cases.
As well as affecting patient outcomes, complications such as leaks or bleeding events can be costly. In the UK, for example, prolonged air leaks were found to occur in 27% of patients undergoing thoracic surgery, at an average additional 90-days postoperative cost of €5,200 per patient. Another Swiss study found that bleeding events affected 8% of thoracic surgery cases, at an average additional cost of over €26,000.
Surgical stapling technology backed by real-world evidence
Since 2017, the use of Johnson & Johnson's Surgical Stapling devices have been associated with improved clinical and economic outcomes — across tissue types, patient populations and countries — in bariatric, thoracic and colorectal procedures.
The OTTAVA Robotic Surgical System is under development and is not authorized to be marketed or sold in any market. CE marking pending.
