J&J's Ottava Robotic System Meets Primary Endpoints in Gastric Bypass Surgery Trial
核心洞察
Johnson & Johnson's Ottava Robotic Surgical System (搜索) successfully met all primary safety and performance endpoints in the FORTE trial, a prospective study of 30 patients undergoing Roux-en-Y gastric bypass surgery.
Patients lost an average of 30 pounds (13.6kg) within 30 days post-surgery, with no conversions to open surgery reported during the procedures.
The company has submitted a De Novo application to the FDA based on these results and preclinical data, seeking approval for multiple gastrointestinal procedures including gastric bypass, sleeve surgeries, and upper abdominal operations.
Johnson & Johnson's Ottava Robotic Surgical System (搜索) has achieved a significant milestone in its development, successfully meeting all primary safety and performance endpoints in a pivotal gastric bypass surgery study. The results position the company to challenge established players in the rapidly growing robotic surgery market.
FORTE Trial Demonstrates Clinical Success
The single-arm, open-label FORTE trial (NCT06709261) enrolled 30 patients across six US sites who underwent Roux-en-Y gastric bypass (RYGB) procedures using the Ottava system. RYGB is performed to reduce stomach capacity, restricting food intake and promoting weight loss in patients with obesity (搜索).
During the 30-day observation period following surgery, patients lost an average of 30 pounds (13.6kg). Notably, all procedures were completed robotically with no conversions to open surgery reported, demonstrating the system's reliability and precision in complex gastrointestinal procedures.
FDA De Novo Application Submitted
Based on the FORTE trial results and supporting preclinical data, Johnson & Johnson has submitted a De Novo application to the US Food and Drug Administration. If approved, the Ottava system could be cleared for multiple gastrointestinal procedures, including gastric bypass and sleeve-based surgeries, small bowel resection, hiatal hernia repair, and general upper abdominal surgeries.
Peter Schulam, J&J's Chief Scientific Officer for MedTech, emphasized that the FORTE trial results demonstrate Ottava's ability to integrate into existing hospital infrastructure, which could "remove practical barriers to broader adoption" of robotics in healthcare settings that may have previously been too small for these solutions.
System Design and Market Positioning
The Ottava system incorporates four robotic arms built into a standard-size surgical table, designed specifically for soft tissue surgeries across multiple specialty areas. This design approach aims to address adoption barriers by fitting within existing hospital infrastructure without requiring significant facility modifications.
J&J presented the FORTE study results as an abstract at the 2026 American Society for Metabolic and Bariatric Surgery (ASMBS) Annual Meeting in San Antonio, Texas.
Competitive Landscape
The positive results come as robotic surgeries gain increasing adoption in hospitals worldwide. Currently, Intuitive Surgical dominates the market with a 60.1% share through its da Vinci surgical robot system (搜索), which has achieved widespread uptake due to its "strong installed base, surgeon training programmes and continuous innovation," according to GlobalData analyst Graysen Vigneux.
Johnson & Johnson is positioning itself to capture market share in this expanding field. The company previously secured 510(k) clearance from the FDA for its robotic-assisted bronchoscopy device, MONARCH QUEST (搜索), in March 2025. Additionally, J&J's subsidiary DePuy Synthes markets the VELYS Active Robotic-Assisted System (搜索) for spinal surgeries, which debuted in the US in August 2024.
Strategic Implications
For Johnson & Johnson, the Ottava system represents a strategic expansion of its MedTech portfolio beyond its core pharmaceutical business. The platform's potential approval for multiple upper abdominal procedures could provide broader revenue opportunities and support the company's diversification efforts.
The success of the FORTE trial positions Ottava as a credible competitor in the robotic surgery space, particularly for gastrointestinal procedures where the system has demonstrated both safety and efficacy in complex operations.