Dive Brief:
- Johnson & Johnson has received a CE mark for a surgical stapler designed to work with its Ottava robot, the company said Wednesday.
- Ottava has yet to receive a CE mark, but, as happened in the U.S., J&J has received clearance for a stapler that works with the device ahead of the robot coming to the European market.
- The CE mark clears European surgeons to use the stapler, Ethicon 4000, in open and laparoscopic surgeries immediately and tees up use with Ottava once the robot receives authorization.
Dive Insight:
J&J plans to use its Ethicon devices to help unlock a robotic surgery market that Intuitive Surgical has dominated for decades. As a multi-specialty soft-tissue robot, J&J’s Ottava will compete with Intuitive’s da Vinci devices. J&J said Ethicon 4000 will be available exclusively on Ottava when the stapler received 510(k) clearance last year, although there is no mention of exclusivity in its statement about the CE mark.
Limiting access to Ethicon instruments to Ottava users could encourage surgeons to adopt J&J’s robot. At a TD Cowen event last month, J&J CFO Joseph Wolk said “most robotic procedures today still utilize some form of Ethicon, Johnson & Johnson instrument.”
Surgeons and hospitals want a consistent experience across open, laparoscopic and robotic procedures, Hani Abouhalka, group chairman of surgery at J&J, said at a Barclays event last month. Having a trusted staple line “will be different and important” for Ottava, Abouhalka said. The executive reiterated that J&J will bring Ethicon devices exclusively to Ottava.
Ethicon 4000 builds on J&J’s Echelon 3000 Stapler. Changes include the use of 3D stapling technology, which J&J said is designed to optimize compression. In a paper published in 2024, Ethicon researchers said 3D staples help compress a larger surface area of the tissue. The staples could reduce leak paths by more evenly distributing compression, the researchers said.
J&J is seeking a CE mark for Ottava. The company filed for de novo authorization of the robot in the U.S. in January.
