Johnson & Johnson has developed OTTAVA for procedures corresponding to for gastric bypass. Supply: Adobe Inventory
Johnson & Johnson introduced outcomes from the primary scientific research of the investigational OTTAVA robotic surgical system. The potential, multicenter scientific research evaluated the security and efficiency of the system for gastric-bypass procedures.
Within the 30-patient cohort, the research met its main security and efficiency endpoints via 30 days post-procedure, mentioned J&J. Investigators accomplished all procedures robotically on OTTAVA with out conversion to a non-robotic strategy. Common weight reduction by 30 days after surgical procedure was 30 lb. (13.6 kg).
“The information present encouraging proof relating to the security and efficiency of the OTTAVA Robotic Surgical System in Roux-en-Y gastric bypass procedures,” said Erik Wilson, M.D. He’s chief of minimally invasive and elective basic surgical procedure at UTHealth Houston, director of bariatric surgical procedure at Memorial Hermann-Texas Medical Middle, and lead investigator for the scientific research.
“Continued innovation in bariatric surgical procedure is essential to affected person care, and I’m happy to current these preliminary scientific outcomes,” added Wilson.
The firm used this scientific information, along with preclinical testing, to assist an software to the U.S. Meals and Drug Administration (FDA) for De Novo classification. J&J is concentrating on a sign protecting a number of procedures typically surgical procedure inside the higher stomach, corresponding to gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia restore.
The New Brunswick, N.J.-based firm introduced its outcomes on the 2026 American Society for Metabolic and Bariatric Surgical procedure (ASMBS) Annual Assembly (Summary 4153).
Growth of OTTAVA was delayed due to the COVID-19 pandemic, the FDA granted OTTAVA an investigational machine exemption (IDE) in late 2024. The system accomplished its first instances a 12 months in the past.
J&J targets soft-tissue surgical procedure with its newest system
Johnson & Johnson designed OTTAVA as a multi-specialty soft-tissue surgical robotic. The corporate mentioned it permits a broad vary of procedures throughout a number of specialties. A number of scientific trials will assist these specialties.
The system’s novel structure incorporates 4 robotic arms built-in right into a standard-size surgical desk, eradicating the necessity for a separate growth or carts.
On this research, OTTAVA was put in and used efficiently throughout working rooms at six collaborating hospitals. OR sizes ranged from roughly 243 to 694 sq. ft. (22.5 to 64.4 sq. m).
In 5 of the six websites, OTTAVA carried out procedures in ORs that beforehand had not been used for robotic surgical procedure, together with rooms traditionally thought-about difficult for robotic techniques on account of area constraints.
“Our progress with OTTAVA depends on rigorous preclinical work, disciplined information assortment within the clinic, and tight collaboration with the surgeons who use it – particularly the investigators within the FORTE scientific research,” mentioned Peter Schulam, M.D., Ph.D., and chief scientific officer for MedTech at Johnson & Johnson. “These outcomes additional illustrate how novel structure helps a differentiated strategy the place it issues most: in actual working rooms, with actual sufferers.”
“At every step – from bench to preclinical and now human trial – we’ve got noticed that this technique can enable extra hospital ORs to accommodate robotics,” he mentioned. “These outcomes exhibit that the novel structure can combine into current infrastructure and take away sensible boundaries to broader adoption.”
Contained in the FORTE research of OTTAVA
Within the U.S. alone, greater than two in 5 adults have weight problems. Metabolic and bariatric surgical procedures are efficient, long-term therapy choices for weight reduction administration, mentioned Johnson & Johnson.
Many of those procedures, together with Roux-en-Y gastric bypass, are more and more carried out robotically. Roux‑en‑Y gastric bypass is a necessary intervention within the administration of weight problems, with latest analysis indicating the therapy is handiest and sturdy for extreme weight problems.
The operation is technically demanding relative to different bariatric procedures – requiring each restrictive and reconstructive steps that usually span a number of belly quadrants and leveraging a broad spectrum of surgical duties.
The Security and Efficiency of the OTTAVA Robotic System: A Potential Multi-Middle Analysis (FORTE) Examine (NCT06709261) is a single-arm, open-label scientific trial performed throughout six research websites within the U.S.
The aim of the research is to guage the security and efficiency of OTTAVA via 30 days after Roux-en-Y gastric bypass surgical procedure. J&J included information from the FORTE research, along with supporting preclinical testing, in its software for FDA De Novo classification.
The OTTAVA Robotic Surgical System is beneath improvement and isn’t but licensed to be marketed or bought in any market, famous the corporate.
Editor’s notice: The Robotics Summit & Expo this month is co-located with DeviceTalks Boston. Register now to attend.
