The table-integrated soft-tissue robotic system is cleared for multiple upper-abdomen procedures as Johnson & Johnson prepares a selective U.S. launch and positions OTTAVA against Intuitive Surgical and Medtronic.
Johnson & Johnson said the U.S. Food and Drug Administration granted De Novo authorization for its OTTAVA Robotic Surgical System, allowing the company to enter the soft-tissue robotic surgery market with a selective U.S. commercial launch. The authorization covers multiple general surgery procedures in the upper abdomen, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair. The decision gives Johnson & Johnson a foothold in a market led by Intuitive Surgical’s da Vinci system, while Medtronic’s Hugo robot was approved last year. J&J said OTTAVA’s robotic arms are integrated into the operating table, giving the system a 30% to 50% smaller footprint than traditional boom- and cart-mounted systems and potentially allowing use in operating rooms that could not previously accommodate a robot. The company said it will begin with select U.S. customers while pursuing additional indications and regulatory markets, including plans for launches in Japan and Western Europe. Hani Abouhalka said global robotic surgical procedure penetration is 8%. TD Cowen analyst Michael Nedelcovych said an inguinal hernia repair trial could support a second U.S. regulatory submission early next year, while J.P.Morgan analyst Robbie Marcus said Intuitive Surgical remains the clear favorite because of its physician relationships and integration into hospital workflows and academic programs, adding J&J may wait for urology approvals before a broader launch.