New Brunswick, New Jersey–based J&J unveiled the new stapler midway through last year. Notably, the technology could aid in the future use of the medtech giant’s highly anticipated Ottava surgical robot. Ottava remains investigational globally, with CE mark and FDA de novo approval pending.
The company designed its latest stapler to manage tissue complexities and deliver exceptional staple line integrity. It aims to minimize risk factors for surgical leaks and bleeding complications across specialties. Approval covers open and laparoscopic surgery across the European Union.
Ethicon 4000 features proprietary 3D stapling technology, a redesigned end effector and streamlined reload options. The company said it offers consistency from the first staple to the last to reduce potential leak pathways. Both the Ethicon 4000 stapler and Ethicon 3D Reloads have U.S. FDA approval for open and laparoscopic surgery.
The company said its newest stapler addresses common complications. It reduces staple line interventions due to bleeding by 23% compared to traditional 2D staples, according to a news release. Ethicon 4000 builds on years of surgical stapling expertise to deliver staples with offset closure of the staple legs. This more evenly distributes compression throughout the staple line, improving line integrity, leak resistance and hemostasis.
“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,” said François Gaudemet, president, Surgery EMEA, MedTech, Johnson & Johnson. “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.”
