Johnson & Johnson MedTech (J&J MedTech) has completed the initial clinical procedures using its OTTAVA robotic surgical system as part of an ongoing US-based clinical investigation.
The announcement marks the first human use of the OTTAVA system under a study authorised by the USFood and Drug Administration (FDA).
The procedures were carried out by Dr Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at UT Health Houston, who serves as the study’s lead investigator. The surgeries, including Roux-en-Y gastric bypass, took place at Memorial Hermann-Texas Medical Center and represent the system’s first clinical deployment.
Johnson & Johnson MedTech chief scientific officer Peter Schulam said: “As a company operating at the intersection of biology and technology, clinical evidence generation is the core of our innovation programs to advance surgical technology for patients.
“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.”
The OTTAVA system has been developed as a platform for multi-specialty soft-tissue surgery and is intended to support a wide range of operations, particularly those involving multi-quadrant approaches in the abdominal region.
According to Johnson & Johnson MedTech, the technology is designed to be adaptable across various surgical disciplines, enhancing procedural flexibility for complex cases.
Data collected from the study will be used to evaluate the system’s performance across a spectrum of general surgery procedures.
Johnson & Johnson MedTech has stated that it intends to submit the OTTAVA system for De Novo classification in the US upon study completion.
The proposed application will seek a general surgery indication focused on upper abdominal interventions, including gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair.
The OTTAVA system received investigational device exemption (IDE) clearance from the FDA in November 2024, granting the company authorisation to initiate human clinical trials. The system remains under development and is not currently approved for commercial sale or marketing in any jurisdiction.
Designed with four low-profile robotic arms that can be stowed beneath the operating table, the OTTAVA platform is built around a unified surgical architecture. This configuration is aimed at facilitating robotic, laparoscopic, hybrid, and open surgeries while maximising working space for theatre staff.
The surgical instrumentation integrated into the system draws on the existing expertise of Ethicon, a Johnson & Johnson MedTech company.
The system is also being positioned for future integration with Johnson & Johnson’s Polyphonic digital ecosystem. This digital interface is expected to support data-driven surgical workflows and align with the individual requirements of patients and surgeons.
Johnson & Johnson MedTech has emphasised that the OTTAVA system is part of its broader efforts to enhance surgical capabilities and address technical limitations that currently affect robotic surgery platforms. General surgery is a key business segment for the company, and the OTTAVA programme is seen as a step toward reinforcing its position in this space.
The company has not disclosed the total number of procedures planned for the study or provided a timeline for De Novo submission or potential commercial launch. The ongoing trial will continue across selected US sites under the terms of the IDE granted by the FDA.
