The U.S. Food and Drug Administration (FDA) granted Johnson & Johnson De Novo clearance for the world’s first table-integrated soft tissue robotic surgical system, OTTAVA™. It has been marketed for various procedures in general surgery, such as Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.
“With OTTAVA, we are introducing a new class of surgical robotics devices,” said Tim Schmid, Executive Vice President and Worldwide Chairman, MedTech, Johnson & Johnson. This is the beginning of a new surgical robotics era, one that isn’t just about a new system; it’s about a new way to improve surgical care and care for patients, with technology, clinical insight, and surgical care, with Johnson & Johnson.
The OTTAVA system will be commercially available in the U.S. to selected customers, and Johnson & Johnson will pursue further indications and regulatory approvals while actively pursuing early customer success. OTTAVA is currently being studied in a clinical trial in the U.S. for inguinal hernia procedures.
Designed to drive the evolution of surgery to date and into the future. Its distinctive design, automated capabilities, advanced robotic surgical tools, and ability to integrate with a digital ecosystem open to innovations present a solution that will be perfectly suited to the operating room of today – and tomorrow.
“Surgical robots will be increasingly used for surgical care but, as everyone will see, the last 25 years of surgery will not define the next 25,” said Hani Abouhalka, Company Group Chair, Surgery, MedTech, Johnson & Johnson. “By changing the way people think about architecture, data and even the surgery itself, we have designed OTTAVA to provide clinical and economic advantages for surgeons and hospitals as the future of surgery comes to pass.”
Hospitals and clinical teams are spearheading the progress of surgical care while grappling with the challenges of infrastructure, OR efficiency, data access and an increasing demand for robotic-assisted surgery. These efforts will be complemented by the features designed for OTTAVA to advance the OR, optimize clinical pathways, provide greater insight into surgical data, and expand access to robotic-assisted surgical care. First-generation system features:
Smallest Multi-port Soft tissue Robotic System footprint: The novel architecture enables a robotic arm to be located within the OR table and minimizes space requirements by 30-50% compared to traditional boom and cart-based robotic systems,1 thereby providing additional workspace for surgeons and clinical teams to move, communicate, and care for patients and potentially support more streamlined clinical workflows and experiences.
Automated and pre-defined procedural poses: The four table-integrated arms are controlled by sophisticated software, which facilitates automated pre-defined poses for simplified setting up and down procedures. The twin motion (synchronized motion of the table and arms) ensures safe and seamless patient repositioning and multi-quadrant access to the anatomy with minimal intra-operative motion adjustments.
With many years of experience in open and laparoscopic surgery, the OTTAVA instrumentation portfolio has been optimized to support the innovation of the more prevalent surgical instruments. It, for example, has a two-in-one needle driver that minimizes unintended suture cutting and curved scissors (monopolar) that ensure consistent and complete cuts.
Polyphonic for OTTAVA is a secure, digital solution that integrates learning, media, and data-driven insights to help surgical teams continuously improve throughout the OTTAVA journey.
OTTAVA education is developed to help new and experienced robotic surgeons throughout the learning journey, with the continuous education philosophy of Johnson & Johnson. OTTAVA education, developed in partnership with clinicians, educational professionals, and surgical societies, will help to facilitate safe adoption and consistent performance with virtual, hands-on, and immersive education.
“Variability of surgical outcomes remains a challenge in healthcare,” said Peter Schulam, Chief Scientific Officer, MedTech, Johnson & Johnson. “Connectivity was essential in the next generation of care as medical robotics has been developed to augment surgical skill; OTTAVA has been created with this in mind.”
OTTAV has reached a major regulatory milestone after Johnson & Johnson announced that its robotic surgical system has received FDA market authorization in the United States. The approval marks an important step in expanding the company’s presence in robotic-assisted surgery and demonstrates continued innovation in advanced surgical technologies designed to improve precision, efficiency, and patient outcomes.
OTTAV Receives FDA Market Authorization
The FDA authorization allows OTTAV to enter the U.S. market, where demand for robotic-assisted surgical procedures continues to grow. The system has been developed to support minimally invasive surgery by providing surgeons with enhanced visualization, improved instrument control, and advanced digital capabilities that help streamline complex procedures.
The authorization follows regulatory review of the system’s performance, safety, and effectiveness, positioning OTTAV as a new option within the rapidly evolving robotic surgery landscape.
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