The Food and Drug Administration (FDA) in the US has granted De Novo authorisation for the OTTAVA Robotic Surgical System, the world’s first table-integrated soft tissue robotic system.
The system received marketing approval for its 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.
Tim Schmid, executive vice president, Worldwide Chairman, MedTech, Johnson & Johnson, said: ‘We are pioneering a new category of surgical robotics with OTTAVA. This is the start of the next era in surgery as we deliver not just a new surgical robotics system, but a catalyst for fundamentally better surgical care that is informed by technology, guided by clinical insight, and delivered with care by Johnson & Johnson.’
Johnson & Johnson will commercially launch the OTTAVA system with select customers in the US, focusing on early customer success while working in parallel to advance into additional indications and regulatory jurisdictions over time. A clinical trial for OTTAVA in inguinal hernia procedures is ongoing.
OTTAVA is purpose-built to advance surgery today and where it goes next. Its unique architecture, automated features, next-generation robotic surgical instruments, and connection to an open digital ecosystem create a foundation that fits seamlessly into operating rooms today and supports more digitally enabled, data-driven surgery in the future.
Hani Abouhalka, company group chair, surgery, MedTech, Johnson & Johnson, said: ‘Surgical robotics will play an increasingly important role in surgical care, but it’s clear that what defined the last 25 years of surgery will not define the next 25. By opening up the way we think about architecture, data, and the very workflows of surgery itself, we have designed OTTAVA to deliver clinical and economic benefits and support surgeons and hospitals as the future of surgery unfolds.’
First-generation system features include:
Smallest multi-port soft-tissue robotic system footprint: The architecture integrates robotic arms into the OR table, occupying 30-50% less space than traditional boom- and cart-mounted systems to support more streamlined workflows.
Built for automation: Software controls four table-integrated arms for automated, pre-set poses, simplifying setup and breakdown. Twin motion synchronizes table and arms for seamless patient repositioning and multi-quadrant access with minimal intraoperative adjustments.
Instrumentation optimised for robotic surgery: Includes a two-in-one needle driver designed to reduce unintended suture cutting, and monopolar curved scissors for consistent, 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 together learning, media, and data-driven insights 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 of new and experienced robotic surgeons and has been developed in collaboration with clinicians, educational experts, and surgical societies.
