Johnson & Johnson Completes First Surgeries with OTTAVA Robotic System in Clinical Trial
核心洞察
J&J has successfully performed the first gastric bypass (搜索) surgeries using its OTTAVA (搜索) robotic surgical system at Memorial Hermann-Texas Medical Center, marking a significant milestone in the system's development.
The OTTAVA (搜索) system features a unique design with four arms built into the operating table, targeting multiple procedures in general surgery within the upper abdomen, including gastric bypass (搜索), gastric sleeve (搜索), and hiatal hernia (搜索) repair.
Following completion of the clinical trial, J&J plans to submit the OTTAVA (搜索) system for De Novo authorization to the FDA, aiming to compete with market leader Intuitive Surgical in the growing robotic surgery market.
Johnson & Johnson MedTech has announced the completion of the first surgical cases using its OTTAVA (搜索) robotic surgical system in a clinical trial, marking a significant advancement in the company's robotic surgery program.
Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at UT Health Houston and lead investigator for the clinical study, performed Roux-en-Y gastric bypass (搜索) surgeries using the OTTAVA (搜索) system at Memorial Hermann-Texas Medical Center.
"Surgical robotics is at the forefront of innovation in minimally invasive surgery," said Dr. Wilson, who is also a paid consultant for Johnson & Johnson MedTech. "I am proud to have performed the first clinical study cases with OTTAVA (搜索) and potentially help advance the standard in surgical robotics."
OTTAVA System Design and Capabilities
The OTTAVA (搜索) robotic system is designed as a multi-specialty soft-tissue surgery platform, supporting a broad range of procedures across patient anatomy and surgical specialties. A key differentiating feature is its four arms built into the operating table that can be stored below to free up space for clinical teams, particularly beneficial for complex surgeries requiring a multi-quadrant approach.
Hani Abouhalka, Company Group Chairman of Surgery at Johnson & Johnson MedTech, emphasized the significance of this milestone: "OTTAVA (搜索) is a key innovation in our portfolio of advanced surgical technologies — all of which are designed to transform the surgical experiences across all surgery."
The system received an investigational device exemption (IDE) approval from the U.S. FDA in late 2024, allowing the company to proceed with the clinical trial.
Clinical Trial and Regulatory Strategy
Data from the current investigation aims to support the system's ability to perform a variety of procedures. Upon completion of the study, Johnson & Johnson plans to submit the OTTAVA (搜索) system for De Novo authorization in the United States.
The company is targeting an indication covering multiple procedures in general surgery within the upper abdomen, including:
- Gastric bypass
- Gastric sleeve
- Small bowel resection
- Hiatal hernia repair
"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," said Peter Schulam, M.D., Ph.D., Chief Scientific Officer at Johnson & Johnson MedTech.
Competitive Landscape in Surgical Robotics
The OTTAVA (搜索) system represents J&J's entry into the competitive soft tissue robotic surgery market, where Intuitive Surgical's da Vinci platform currently holds a dominant position. J&J has faced delays in its development timeline but is now progressing toward a de novo submission to the FDA.
The surgical robotics market is becoming increasingly competitive, with Medtronic also targeting FDA approval for its Hugo robot with urology indications. Smaller companies including CMR Surgical (搜索) and Moon Surgical (搜索) have already secured U.S. authorizations for their robotic systems.
Johnson & Johnson already markets the Monarch (搜索) robotic lung biopsy platform and the Velys (搜索) robot for orthopedic applications. The OTTAVA (搜索) system would expand the company's robotic portfolio into general surgery, a significant market segment.
Technology Integration
According to J&J, the OTTAVA (搜索) system's unique unified architecture, surgical instrumentation powered by Ethicon expertise, and future connection to the Polyphonic digital ecosystem are designed to meet the needs of each patient's care and each surgeon's clinical approach.
The company positions OTTAVA (搜索) as addressing unmet needs that persist in robotic surgery today, particularly for complex procedures that require a multi-quadrant approach.
As robotic systems become increasingly utilized across surgical specialties, J&J's advancement with OTTAVA (搜索) represents a significant step in the evolution of minimally invasive surgery technology and the company's commitment to innovation in surgical care.