SHERIDAN, WYOMING – May 5, 2025 – Johnson & Johnson MedTech has marked a significant milestone in the evolution of robotic-assisted surgery by completing the first clinical trial cases of its OTTAVA™ Robotic Surgical System. This development positions the company at the forefront of innovation in minimally invasive procedures, reinforcing its strategic commitment to delivering cutting-edge surgical technologies that raise standards in operating rooms worldwide.
Strategic Leap in Robotic-Assisted Surgery
The inaugural clinical cases for the OTTAVA system were led by Dr. Erik Wilson, Chief of Minimally Invasive and Elective General Surgery at UT Health Houston, who performed Roux-en-Y gastric bypass surgeries at Memorial Hermann-Texas Medical Center. These procedures represent the first real-world clinical application of the OTTAVA system and a pivotal moment in its developmental journey.
“Surgical robotics is at the forefront of innovation in minimally invasive surgery,” said Dr. Wilson. “I am proud to have performed the first clinical study cases with OTTAVA and potentially help advance the standard in surgical robotics.”
By integrating advanced instrumentation and digital capabilities, the OTTAVA system is designed as a multi-specialty platform capable of performing a range of complex, soft-tissue procedures—particularly in areas requiring multi-quadrant access.
Clinical Evidence to Drive Regulatory Path
Data generated from this clinical investigation will support Johnson & Johnson MedTech’s upcoming submission for De Novo authorization from the U.S. Food and Drug Administration. The company is targeting indications in general upper abdominal surgeries such as:
- Gastric bypass
- Gastric sleeve
- Small bowel resection
- Hiatal hernia repair
This regulatory pathway underscores the company’s evidence-based approach to innovation and its strategy to expand access to advanced surgical care across diverse clinical settings.
Technological Differentiation and Industry Relevance
OTTAVA's unique unified architecture reflects Johnson & Johnson MedTech’s commitment to addressing key unmet needs in robotic surgery. Powered by Ethicon’s instrumentation and designed for future integration with the Polyphonic™ digital ecosystem, the system offers:
- Enhanced versatility across multiple surgical specialties
- Scalable integration with data-driven tools
- Support for a variety of complex procedures
- Focused design around both patient outcomes and surgical team workflows
“We are proud to reach this important milestone in our robotic surgery program,” said Hani Abouhalka, Company Group Chairman, Surgery, Johnson & Johnson MedTech. “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.”
OTTAVA’s development aligns with broader industry trends emphasizing precision, personalization, and the digital transformation of operating rooms. Its entry into clinical trials further strengthens Johnson & Johnson MedTech’s positioning in the competitive robotic surgery landscape, currently led by a few key players.
A Commitment to Evidence-Based Innovation
With IDE (Investigational Device Exemption) approval secured in late 2024, OTTAVA advances Johnson & Johnson MedTech’s long-term vision of fusing biology with technology to enhance clinical outcomes.
“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,” said Peter Schulam, M.D., Ph.D., Chief Scientific Officer, Johnson & Johnson MedTech. “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.”
Looking Ahead
While the OTTAVA system remains under development and is not yet commercially available, its clinical debut marks a strategic advancement in Johnson & Johnson MedTech’s mission to transform surgical care through innovation, integration, and global reach.