J&J Brings Ottava into the Forefront of Surgical Robotics with New IDE Approval

Johnson & Johnson has won an IDE to begin a clinical trial of the Ottava Robotic Surgical System.

The New Brunswick, NJ-based company submitted for IDE approval nearly a month ago after a delay in pursuing a nod from FDA.

The Ottava system features four, low-profile robotic arms incorporated into the operating table that can be stowed underneath.  This unified architecture allows for a compact footprint designed to support robotic, laparoscopic, hybrid, and open surgery with more working space for clinical teams.

The system's architecture supports clinically relevant features like "twin motion," in which the table and robotic arms move together for intraoperative repositioning and multi-quadrant access without re-docking.

"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," said Hani Abouhalka, Company Group Chairman, Surgery, J&J MedTech. "Meeting this milestone brings us a step closer to delivering on our promise to make technology more human, care more adaptive, and people more connected so that surgery works better for everyone."

Nearly four years ago, J&J revealed Ottava.  However, a year after the reveal, J&J announced it was going to delay its robotics program by about two years.

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The seeds for Ottava were planted when J&J bought out Verily’s remaining stake in the Verb surgical robotics joint venture. J&J continued to build out its surgical robotics platform with the $3.4 billion acquisition of Auris Health. The Redwood City, CA-based company’s acquisition provided J&J with the Monarch Platform, an FDA cleared system used in bronchoscopic diagnostic and therapeutic procedures. The acquisition also lead to Frederic Moll, MD, a certified legend in the surgical robotics market joining J&J.

When and if the Ottava wins approval from FDA, the platform will have steep competition in the soft tissue surgical robotics space. Intuitive Surgical, a pioneer in the market, is currently soaring high off a limited launch of the Dv5 platform.

The device won a nod from FDA in March and news of the demand caused the Sunnyvale, CA-based company’s shares to surge more than 10% last month.

J&J’s other competitor is Medtronic with the Hugo robotic-assisted surgery system. Hugo has CE mark but doesn’t have FDA approval. A modular system, Hugo combines wristed instruments, 3D visualization, and Medtronic's Touch Surgery Enterprise, a cloud-based surgical video capture and management solution, with dedicated support teams specializing in robotics program optimization, service, and training. Touch Surgery Enterprise is an AI-powered platform designed to make sharing surgical video simple and provides surgeons with a powerful new training tool

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