Medical Device Network

Johnson & Johnson plan clinical trial for surgical robot

OTTAVA robotic surgical system from Johnson & Johnson MedTech is to be submitted for an investigational device exemption application with the FDA.

Industry giant Johnson & Johnson plans to submit its OTTAVA robotic surgical system to the US Food and Drug Administration (FDA) for an investigational device exemption (IDE) application status.

The planned submission will take place in the second half of 2024 and will initiate the start of clinical trials of the system.

The OTTAVA robotic surgical system uses four robotic arms on a standard size surgical table. The arms make surgery flexible and are designed to help surgeons tackle important clinical needs during surgery, allowing them to reposition a patient without interrupting the procedure. The robotic arms can also be stowed under the operating table and adapt to each patients’ requirements.

“Today, the majority of operating room (ORs) are not robotic because they were not built with a robot in mind,” said Dr Eduardo Parra-Davila, General Surgeon at the Palm Beach Digital Institute and paid consultant at Johnson & Johnson MedTech.

He added: "The industry needs a system that is adaptable, easy to use in any OR in the world, and maintains space in the OR. As surgeons, we need space to improve the workflow in the OR, increase safety, and enable 360-degree patient access so we can perform at the capacity that we would like to. That's where OTTAVA comes in. OTTAVA offers a unique design that incorporates into any OR and allows surgeons to do what they would like to do and know how to do, which is focus on the patient."

The system uses Ethicon instrumentation for better performance and precision to give surgeons consistent experience between traditional laparoscopic and robotic procedures.

Dr Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at the University of Texas Health Science Center in Houston and paid consultant at Johnson & Johnson MedTech commented: "Often today, I am required to use instruments with variable utility and functionality between traditional laparoscopic procedures and robotic-assisted procedures. Access to the reliable Ethicon laparoscopic instruments on a robotic platform would be useful to operate with less variability regardless of surgical modality."

One of the first robotic systems FDA approved for general laparoscopic surgery was the da Vinci Surgical System, developed by Intuitive Surgical. It is one of the most used systems and dominates the market for robotic surgical systems used in general surgeries, with over 90% market share.