Johnson & Johnson MedTech today announced plans to submit the OTTAVA robotic surgical system for an investigational device exemption (IDE) application to the U.S. Food & Drug Administration (FDA) in the second half of 2024 to initiate clinical trials.
The system is designed to create space in the operating room (OR), simplify complex workflows, enable flexibility for clinical approaches, and deliver the trusted performance of Ethicon instrumentation.
"Johnson & Johnson was born in surgery with the advent of sterile sutures, and we have since helped surgeons improve care for patients by offering transformative technologies across all types of surgery," said Hani Abouhalka, Company Group Chairman, Robotics & Digital, Johnson & Johnson MedTech. "We believe the future of surgery is personal. Starting with the human impact – the connection between the patient, surgeon, and OR staff – we are unlocking what science and technology can do to improve the surgical experience and health outcomes for everyone involved. OTTAVA is designed to consistently deliver this experience in any OR globally."
OTTAVA incorporates four robotic arms into a standard size surgical table. This unified architecture allows for an invisible design, with the robotic arms available when needed or stowed under the surgical table when not. The design removes barriers to movement and collaboration in robotic operating rooms and offers surgical teams the freedom and flexibility to adapt to clinical workflows and individualized patient needs.
The system's "twin motion" feature – unified movement of the table and the robotic arms – is designed to allow surgical teams to address important clinical needs during surgery, such as the ability to reposition a patient without interrupting the procedure.
OTTAVA exclusively features trusted Ethicon instrumentation, designed for performance and precision, and offers surgeons a more consistent experience between traditional laparoscopic and robotic procedures. Ethicon instruments on OTTAVA are backed by decades of innovation and market leadership in minimally invasive surgery, providing leading device-to-tissue and user-to-device interactions.
When authorized for commercial launch, OTTAVA will join Johnson & Johnson MedTech's portfolio of commercially available robotic systems, including the MONARCH Platform and the VELYS Robotic-Assisted Solution, and will be backed by the company's global team of specialists in surgical education and clinical training.