Johnson & Johnson today announced that the FDA has granted De Novo authorization for the OTTAVA Robotic Surgical System, which the company called the world’s first table-integrated soft tissue robotic system.
The system received marketing authorization for multiple procedures in general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication and hiatal hernia repair.
Johnson & Johnson will commercially launch the OTTAVA system with select customers in the U.S., focusing on early customer success while working in parallel to advance into additional indications and regulatory jurisdictions over time. A U.S. clinical trial for OTTAVA in inguinal hernia procedures is ongoing.
OTTAVA is designed with features intended to help enhance OR capacity, streamline clinical workflows, improve visibility into surgical data, and support broader access to robotic-assisted surgical care. First-generation system features include:
- Smallest multi-port soft-tissue robotic system footprint: The novel architecture integrates robotic arms into the OR table and occupies 30–50% less space than traditional boom- and cart-mounted systems, creating additional room for surgeons and clinical teams to move, communicate, and care for patients, with the potential to support more streamlined clinical workflows and experiences.
- Built for automation: Sophisticated software controls coordinate the four table-integrated arms, enabling automated, pre-defined procedural poses to simplify setup and breakdown. Twin motion, which is the synchronized motion of the table and arms, provides seamless patient repositioning and multi-quadrant access to the anatomy with limited intraoperative adjustments.
- Instrumentation optimized for robotic surgery: Based on generations of clinical experience in open and laparoscopic surgery, the OTTAVA instrumentation portfolio has been reimagined to drive innovation for the more commonly used surgical tools. For instance, the system features a two-in-one needle driver designed to reduce unintended suture cutting, and monopolar curved scissors for consistent and complete cuts.
- Connected to the Polyphonic digital ecosystem: Polyphonic for OTTAVA is a secure digital solution designed to support surgical teams throughout the OTTAVA experience – bringing learning, media, and data-driven insights together to support continuous improvement across the surgical journey.
- Backed by Johnson & Johnson’s legacy in continuous education: OTTAVA education is designed to support the learning journey for new and experienced robotic surgeons. Developed in collaboration with clinicians, educational experts, and surgical societies, OTTAVA education will support safe adoption and consistent performance through virtual, hands-on and immersive training.
