Johnson & Johnson MedTech reported that it has completed the first U.S. clinical cases of its Ottava surgical robot, with a minimally invasive gastric bypass procedure in Texas.
J&J received a thumbs-up from the FDA last fall to launch human trials of the system, which is designed for both laparoscopic and open surgeries of soft tissue, as well as hybrid combinations of the two approaches.
Ottava was once set to make its first-in-human debut in late 2022, but its development was pushed back due to technical challenges and disruptions during the COVID-19 pandemic.
The company said that once this study is complete, it plans to use the data to pursue a de novo clearance at the FDA—a initial green light that would cover multiple general surgery procedures in the upper abdomen, such as gastric bypass and sleeve operations, as well as small bowel resections and hiatal hernia repairs.
In the trial, the system was employed at Memorial Hermann-Texas Medical Center in Houston for a Roux-en-Y procedure, which creates a smaller pouch within the stomach and connects it to the small intestine.
“We are proud to reach this important milestone in our robotic surgery program,” Hani Abouhalka, group chairman for surgery at J&J MedTech, said in a statement. “Ottava is a key innovation in our portfolio of advanced surgical technologies—all of which are designed to transform the surgical experiences across all surgery.”
According to J&J, Ottava is designed to fit within nearly any operating room, with four robotic arms incorporated into the motorized table that can be folded and stowed underneath. It will exclusively employ instruments from J&J’s Ethicon division.
The table itself can move in concert with the robotic arms to help reposition the patient without fully pausing the procedure.