FDA approves Johnson & Johnson’s Ottava surgical robot for human trials

FDA approves Johnson & Johnson’s Ottava surgical robot for human trials

USA – Johnson & Johnson MedTech has secured FDA clearance to begin human clinical trials for its Ottava surgical robot, a development that could reshape robotic surgery options.

Ottava is designed to accommodate various surgical types, including laparoscopic, hybrid, and open procedures, providing flexibility for operating room setups.

Unlike traditional robotic systems, Ottava’s four arms are built directly into a motorized table, which keeps them compactly stored when not in use. This feature enables a small footprint that’s compatible with nearly any surgical environment.

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Following this FDA approval, J&J is preparing to train clinical study investigators on Ottava’s operations and how to use its Ethicon surgical instruments. U.S. patient enrollment is expected soon, allowing the robot to be tested in real surgical cases.

J&J’s group chairman of surgery, Hani Abouhalka, emphasized, “We are bringing the best of J&J MedTech’s surgery expertise to the Ottava system and taking a holistic view of the science of surgery to enable new experiences across all surgical modalities in service of patients around the world.”

Targeting market giants in robotic surgery

With Ottava, J&J is positioning itself to rival Intuitive Surgical, the dominant force in robotic-assisted surgery for over two decades.

Intuitive’s da Vinci system recently introduced updates that physicians have responded positively to, raising the bar for competitors.

Medtronic’s Hugo robot, currently available in Europe, Japan, and Canada, is also vying for a share of the market alongside smaller players like CMR Surgical.

Ottava is designed to address unmet needs that persist in robotic surgery,” J&J stated, highlighting the robot’s potential to enhance surgical choice and competition.

The system’s modular design, combined with the Ethicon instrumentation, aims to bridge robotic and traditional laparoscopic techniques, promoting greater consistency.

Developing from Verb Surgical and integrating with J&J’s Polyphonic Network

Ottava’s development traces back to a collaboration with Google’s Verily, initially known as Verb Surgical, which J&J later acquired.

This merger also brought in Auris Health’s robotics technology, although a recent court ruling found J&J at fault for neglecting to develop Auris’ iPlatform robot. The court awarded US $1 billion to Auris’ investors as part of this decision.

Originally set for a first-in-human trial in late 2022, Ottava’s debut was delayed by technical challenges and the COVID-19 pandemic.

The current trials mark a new phase for J&J as it steps up competition against larger robotic systems like da Vinci.

J&J’s approach with Ottava emphasizes adaptability and efficiency with its compact, integrated table-arm design, as well as a digital ecosystem, Polyphonic, that provides surgeons with real-time access to patient analytics and operative feedback.

Through the Polyphonic platform, J&J offers surgeons the ability to monitor patient progress from pre-op to discharge.

Polyphonic also enables surgical teams to remotely observe procedures, tag and annotate video segments, and share critical insights with colleagues.

This innovative network aims to build a collaborative environment that supports both patient outcomes and surgical advancements.