Johnson & Johnson MedTech today announced that the FDA has approved the OTTAVA robotic surgical system investigational device exemption (IDE), which allows the clinical trial to begin at U.S. sites. The company will now prepare clinical trial sites to receive OTTAVA systems, enroll patients, and begin surgical cases.
The OTTAVA System features a unified architecture, surgical instrumentation powered by Ethicon expertise, and Johnson & Johnson MedTech’s digital ecosystem. It features four low-profile robotic arms incorporated into the operating table that can be stowed underneath. This unified architecture allows for a compact footprint designed to support robotic, laparoscopic, hybrid, and open surgery with more working space for clinical teams.
The system’s architecture supports clinically relevant features like “twin motion,” in which the table and robotic arms move together for intraoperative repositioning and multi-quadrant access without re-docking.
The OTTAVA system will exclusively feature Ethicon instrumentation, designed for a more consistent experience between traditional laparoscopic and robotic procedures. Ethicon instruments designed for OTTAVA are backed by decades of innovation and market leadership in minimally invasive surgery, providing leading device-to-tissue and user-to-device interactions.
Johnson & Johnson MedTech’s Polyphonic digital ecosystem will connect the portfolio across world-class surgical technologies, robotics, and surgical software while leveraging the global scale of Johnson & Johnson. In the future, Polyphonic will empower OTTAVA with data and advanced insights that will support clinical decision making, learning, and collaboration.
The OTTAVA robotic system is under development and is not authorized to be marketed or sold in any market.
