Johnson & Johnson (J&J) has received European CE mark approval for the ETHICON 4000 Stapler, which offers staple line integrity across diverse tissue thicknesses.
The approval allows the device and its associated ETHICON 3D Reloads to be used in open and laparoscopic surgery throughout the European Union.
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The stapling technology will also be available for future use with the OTTAVA Robotic Surgical System.
This stapler incorporates proprietary 3D Stapling Technology, a redesigned end-effector, and streamlined reload options.
The device and reloads offer solutions for both open and minimally invasive surgical procedures and are intended to address a range of surgical applications in the future, including use with robotic platforms.
J&J MedTech surgery EMEA president François Gaudemet said: “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.
“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.”
J&J reported that surgeons face complex variables like thick, fragile, and inconsistent tissues that may compromise staple line stability and therefore patient outcomes.
Some studies indicate frequent reinforcement of staple lines; for instance, 77% of bariatric surgeons reinforce the staple line during laparoscopic sleeve gastrectomy.
These complications may also have significant cost impacts, as demonstrated by a UK study reporting prolonged air leaks in 27% of thoracic surgery patients, costing an additional €5,200 ($6,099.8) over 90 days, and a Swiss study noting bleeding events in 8% of thoracic cases with costs exceeding €26,000.
The OTTAVA Robotic Surgical System is still under development and has not yet received market authorisation.
Earlier this month, J&J reported interim 12-month results from the VARIPURE study, assessing the effectiveness and safety of its Varipulse pulsed field ablation (PFA) platform in first-time users.
