The FORTE study involved 30 patients undergoing Roux-en-Y gastric bypass at six U.S. hospitals.
Ottava met primary safety and performance endpoints through 30 days post-procedure.
All procedures completed robotically without conversion to non-robotic approaches.
Patients lost an average of 30 pounds by 30 days post-surgery.
Results support FDA De Novo application for upper abdominal surgeries including gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair.
System used successfully in ORs sized 243-694 sq ft.
Data presented at 2026 ASMBS Annual Meeting in San Antonio, Texas.