Johnson & Johnson has developed OTTAVA for procedures corresponding to for gastric bypass. Supply: Adobe Inventory
Johnson & Johnson introduced outcomes from the primary medical examine of the investigational OTTAVA robotic surgical system. The possible, multicenter medical examine evaluated the protection and efficiency of the system for gastric-bypass procedures.
Within the 30-patient cohort, the examine met its major security and efficiency endpoints via 30 days post-procedure, stated J&J. Investigators accomplished all procedures robotically on OTTAVA with out conversion to a non-robotic method. Common weight reduction by 30 days after surgical procedure was 30 lb. (13.6 kg).
“The info present encouraging proof concerning the protection and efficiency of the OTTAVA Robotic Surgical System in Roux-en-Y gastric bypass procedures,” acknowledged Erik Wilson, M.D. He’s chief of minimally invasive and elective normal surgical procedure at UTHealth Houston, director of bariatric surgical procedure at Memorial Hermann-Texas Medical Heart, and lead investigator for the medical examine.
“Continued innovation in bariatric surgical procedure is necessary to affected person care, and I’m happy to current these preliminary medical outcomes,” added Wilson.
The corporate used this medical knowledge, along with preclinical testing, to assist an utility to the U.S. Meals and Drug Administration (FDA) for De Novo classification. J&J is focusing on a sign protecting a number of procedures generally surgical procedure throughout the higher stomach, corresponding to gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia restore.
The New Brunswick, N.J.-based firm offered 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 yr 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 stated it permits a broad vary of procedures throughout a number of specialties. A number of medical 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 increase or carts.
On this examine, OTTAVA was put in and used efficiently throughout working rooms at six taking part 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 attributable to house constraints.
“Our progress with OTTAVA depends on rigorous preclinical work, disciplined knowledge assortment within the clinic, and tight collaboration with the surgeons who use it – particularly the investigators within the FORTE medical examine,” stated 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 method 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 noticed that this method can permit extra hospital ORs to accommodate robotics,” he stated. “These outcomes exhibit that the novel structure can combine into current infrastructure and take away sensible obstacles to broader adoption.”
Contained in the FORTE examine 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 remedy choices for weight reduction administration, stated 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 an important intervention within the administration of weight problems, with latest analysis indicating the remedy is best and sturdy for extreme weight problems.
The operation is technically demanding relative to different bariatric procedures – requiring each restrictive and reconstructive steps that sometimes 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-Heart Analysis (FORTE) Examine (NCT06709261) is a single-arm, open-label medical trial carried out throughout six examine websites within the U.S.
The aim of the examine is to judge the protection and efficiency of OTTAVA via 30 days after Roux-en-Y gastric bypass surgical procedure. J&J included knowledge from the FORTE examine, along with supporting preclinical testing, in its utility for FDA De Novo classification.
The OTTAVA Robotic Surgical System is beneath improvement and isn’t but licensed to be marketed or offered in any market, famous the corporate.
Editor’s observe: The Robotics Summit & Expo this month is co-located with DeviceTalks Boston. Register now to attend.
The submit Johnson & Johnson completes medical examine for OTTAVA robotic surgical system appeared first on The Robotic Report.
