J&J Seeks FDA De Novo for Ottava After 30-Patient, 30-Lb Loss Study
JNJ•Johnson & Johnson’s Ottava Robotic Surgical System met all primary safety and performance endpoints in a 30-patient FORTE Roux-en-Y gastric bypass study, with participants losing an average of 30 pounds over 30 days. J&J has filed for De Novo FDA classification to expand Ottava’s use across multiple gastrointestinal procedures.
1. FORTE Trial Demonstrates Safety and Efficacy
Johnson & Johnson’s Ottava Robotic Surgical System met all primary safety and performance endpoints in the single-arm FORTE study, which involved 30 Roux-en-Y gastric bypass patients monitored over 30 days and saw an average weight loss of 30 pounds per patient.
2. De Novo Application Targets Broad GI Use
J&J has submitted its De Novo classification request to the FDA based on FORTE results and preclinical data, aiming to secure clearance for Ottava to perform multiple gastrointestinal procedures including gastric bypass, sleeve surgeries, small bowel resections and hiatal hernia repairs.
3. Competitive Landscape in Surgical Robotics
Ottava’s table-integrated four-arm design could lower adoption barriers in smaller hospitals, positioning J&J to challenge Intuitive Surgical’s 60.1% market share of da Vinci systems and expand its medtech footprint following prior clearance of the Monarch Quest bronchoscopy device.
