While J&J has kept its Ottava robot under wraps, it said the system offers surgical teams the ability to adapt to clinical workflows and individual patient needs. | Source: Johnson & Johnson
Johnson & Johnson MedTech this week announced that it has completed the first cases in the clinical trial for its OTTAVA Robotic Surgical System. The cases mark the first clinical experience with the OTTAVA System, it said.
“We are proud to reach this important milestone in our robotic surgery program,” said Hani Abouhalka, the company group chairman of surgery at Johnson & Johnson MedTech.
“OTTAVA is a key innovation in our portfolio of advanced surgical technologies – all of which are designed to transform the surgical experiences across all surgery,” he added. “Our people work side-by-side with surgical teams in ORs [operating rooms] around the world every day to raise the standard of care for patients and deliver what’s next in surgery.”
Johnson & Johnson MedTech is a unit of New Brunswick, N.J.-based Johnson & Johnson (J&J), which has more than 100 years of experience in medicine and surgical technology. The company said its portfolio includes robotics, wound closure, adjunctive hemostats, surgical stapling and instruments, and digital systems.
OTTAVA addresses surgical robotics shortcomings
The U.S. Food and Drug Administration (FDA) granted OTTAVA an investigational device exemption in late 2024. Johnson & Johnson MedTech said it designed the system to advance clinical innovation in general surgery, a significant part of its broader surgery business.
J&J described OTTAVA as “a multi-specialty soft-tissue surgery robot, supporting a broad range of procedures across patient anatomy and surgical specialties, including the most complex surgeries that require a multi-quadrant approach.” The system’s unified architecture, surgical instrumentation built on J&J’s Ethicon experience, and a planned connection to the Polyphonic digital ecosystem are intended to meet the needs of each patient’s care and each surgeon’s clinical approach, the company asserted.
Johnson & Johnson MedTech first shared details about OTTAVA about four years ago. Since then, it has been relatively quiet. In October 2021, the company pushed back the platform’s development timeline by about two years, citing multiple factors.
OTTAVA’s initial design included six robotic arms. In November 2023, a J&J update included changes, including four arms to be available on demand.
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Johnson & Johnson MedTech preps for next steps
Dr. Erik Wilson is the chief of minimally invasive and elective general surgery at the University of Texas Health Houston and the lead investigator for the clinical study. He performed a Roux-en-Y gastric-bypass surgery using the OTTAVA Robotic Surgical System at Memorial Hermann-Texas Medical Center.
“Surgical robotics is at the forefront of innovation in minimally invasive surgery,” said Wilson. “I am proud to have performed the first clinical study cases with OTTAVA and potentially help advance the standard in surgical robotics.”
Johnson & Johnson MedTech plans to use data from this trial aims to support the surgical system’s ability to perform a variety of procedures. Upon completion of the study, the company plans to submit the OTTAVA system for De Novo authorization in the U.S.
J&J said it will target an indication covering multiple procedures in general surgery within the upper abdomen. These include gastric bypass, gastric sleeve, small bowel resection, and hiatal hernia repair.
“As a company operating at the intersection of biology and technology, clinical evidence generation is the core of our innovation programs to advance surgical technology for patients,” said Peter Schulam M.D., Ph.D., and chief scientific officer at Johnson & Johnson MedTech. “Through this clinical study, we are proud to be partnering with surgeons to gather evidence and support the ongoing pursuit of scientific study for the advancement of robotic-assisted minimally invasive surgery.”
The OTTAVA robotic system is under development and is not yet authorized to be marketed or sold in any market, noted J&J.
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