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.

Johnson & Johnson MedTech is building on its global portfolio of surgical technologies to advance Ottava and help surgical teams and hospitals provide more patients with the benefits of robotic surgery. The system is designed to address unmet needs that persist in robotic surgery today, while driving choice and competition in an underpenetrated and high-growth market.

“We are excited about reaching this important milestone and progressing our differentiated general surgery robotic platform for the benefit of patients and surgeons,” said Rocco De Bernardis, President, Ottava, Johnson & Johnson MedTech. “With approval to move to clinical investigation, our teams are focused on training clinical trial investigators and teams as they enroll patients and prepare for cases.”

A differentiated approach to robotic surgery

The Ottava System is designed to set a new standard for the modern operating room (OR) and transform the surgical experience. The system’s unique unified architecture, surgical instrumentation powered by Ethicon expertise, and Johnson & Johnson MedTech’s digital ecosystem are intended to provide versatility to meet the needs of each patient’s care and each surgeon’s clinical approach.

The Ottava system 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 surgeon-trusted Ethicon instrumentation, designed for performance and precision and 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. For more information, visit: http://thenext.jnjmedtech.com/surgical-robotics.