Johnson & Johnson MedTech has initiated the clinical trial phase for its OTTAVA robotic surgical system, completing its first patient procedures with the platform.

OTTAVA is designed to be a multispecialty robotic platform for soft-tissue procedures, with a focus on supporting complex surgeries requiring multi-quadrant access. According to the company, the current clinical study is intended to evaluate the system’s performance across a variety of general surgery procedures in the upper abdomen.

Dr. Erik Wilson, chief of minimally invasive and elective general surgery at UT Health Houston, performed Roux-en-Y gastric bypass surgeries using the system at Memorial Hermann-Texas Medical Center. Wilson is serving as the lead investigator in the ongoing study.

“Surgical robotics is at the forefront of innovation in minimally invasive surgery,” Wilson said. “I am proud to have performed the first clinical study cases with OTTAVA and potentially help advance the standard in surgical robotics.”

Upon completion of the trial, Johnson & Johnson MedTech plans to seek De Novo authorization from the U.S. Food and Drug Administration. If approved, the system could be cleared for indications including gastric bypass, gastric sleeve, small bowel resection and hiatal hernia repair.

The system received investigational device exemption from the FDA in late 2024, allowing the company to proceed with human trials. The device incorporates surgical instrumentation developed through Ethicon and is expected to interface with Johnson & Johnson’s Polyphonic digital ecosystem in the future.

Peter Schulam, chief scientific officer at Johnson & Johnson MedTech, emphasized the company's focus on evidence-driven development. “Through this clinical study, we are proud to be partnering with surgeons to gather evidence and support the ongoing pursuit of scientific study for the advancement of robotic-assisted minimally invasive surgery,” Schulam said.

The OTTAVA system is still under development and not yet approved for commercial use.