July 22 (Reuters) - Johnson & Johnson said on Wednesday the U.S. Food and Drug Administration had granted marketing authorization for its robotic surgery device, as the healthcare conglomerate enters the soft-tissue robotic surgery market.
The decision marks a key step for J&J's medtech business that had been seeking to compete in the robotic-assisted surgery market, currently dominated by Intuitive Surgical's da Vinci system. Medtronic's Hugo robot was also approved last year.
J&J's Ottava robotic surgical system was authorized for use in multiple general surgery procedures in the upper abdomen, including gastric bypass, gastrectomy, gallbladder removal, gastric sleeve surgery, appendectomy and hiatal hernia repair.
The company said it would begin a U.S. commercial launch with select customers, while working on expanding the system into additional indications and regulatory markets.
"Our intention is to lead in surgical robotics... we're also planning fast launches in key markets globally, like Japan and Western Europe," said Hani Abouhalka, chairman of surgery at J&J MedTech, adding the global robotic surgical procedure penetration is 8%.
TD Cowen analyst Michael Nedelcovych said another trial in inguinal hernia repair - one of the most common surgeries in the U.S. - can be conducted in a timely fashion, yielding a second U.S. regulatory submission for the system early next year.
The company said Ottava's robotic arms are integrated directly into the operating table, and therefore the device occupies 30% to 50% less space than traditional boom-and-cart-mounted systems used by most surgical robots.
J&J said its device has the potential to work in operating rooms that could not previously accommodate a robotic system.
"While Ottava has some interesting selling points (smaller footprint), our doc checks continue to point to Intuitive as the clear favorite given its physician relationships and entrenched integration into the hospital workflow and academic programs," J.P.Morgan analyst Robbie Marcus said in a note.
Marcus added that, like Medtronic, J&J could also wait for the urology indications to be approved before initiating a full launch.
(Reporting by Puyaan Singh in Bengaluru; Editing by Joyjeet Das and Shinjini Ganguli)
