Johnson & Johnson's Ottava Robotic Surgical System Receives FDA Approval

Johnson & Johnson (J&J) has received marketing authorization from the US Food and Drug Administration (FDA) for its Ottava robotic surgical system, clearing the healthcare major to enter the fast-growing soft-tissue robotic surgery market. The approval is an important milestone for J&J’s medical technology business as it seeks to challenge Intuitive Surgical, whose da Vinci system dominates robotic-assisted surgery. Medtronic’s Hugo surgical robot was approved last year. Ottava has been authorized for several general surgery procedures involving the upper abdomen. These include gastric bypass, gastrectomy, gallbladder removal, gastric sleeve surgery, appendectomy and hiatal hernia repair.

US launch to begin with select customers

J&J said that it would initially introduce Ottava to select customers in the United States. The company also plans to seek approval for additional procedures and expand the system into more international markets. “Our intention is to lead in surgical robotics,” said Hani Abouhalka, chairman of surgery at J&J MedTech. He added that the company was preparing for rapid launches in markets including Japan and Western Europe. According to Abouhalka, robotic systems are currently used in only about 8% of surgical procedures worldwide, leaving significant room for growth. "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," JP Morgan analyst Robbie Marcus said in a note.

Ottava promises a smaller operating-room footprint

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. Unlike many surgical robots that rely on boom- or cart-mounted equipment, Ottava’s robotic arms are integrated directly into the operating table. The smaller footprint could allow hospitals to install Ottava in operating rooms that previously could not accommodate a robotic surgical system. However, analysts said J&J faces a difficult challenge in dislodging Intuitive Surgical.