Johnson & Johnson plans to submit Ottava surgical robot for FDA IDE next year

On Nov 7, 2023

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Martin Buehler giving a keynote talk at the Robotics Summit & Expo. | Credit: Jeff Pinette

Johnson & Johnson MedTech (NYSE: JNJ) today outlined its plan to submit its new Ottava surgical robot to the FDA.

The company first shared details on the Ottava surgical robotic platform nearly three years ago. It highlighted the potential for unrivaled flexibility and control compared to the rest of the market. The first look at the surgical robot marked a significant step into the surgical robotic space dominated by Intuitive Surgical over the past two decades. J&J joined the list of companies, both large and small, aiming to take Intuitive on in the soft-tissue robotics arena.

Since that day in November 2020, Johnson & Johnson MedTech has remained quiet on the topic, though. In October 2021, it pushed back the platform’s development timeline by about two years due to multiple factors. J&J initially expected to begin the verification and validation processes for Ottava in 2021. The company planned for enrollment in clinical trials for the device in 2022 to follow.

‘Stay tuned’

At the Robotics Summit & Expo in May, Martin Buehler, global head of robotics R&D, gave the last update on Ottava.

“Stay tuned,” he said during a keynote presentation. “It’s happening.”

Buehler hoped to provide a “big reveal” on Ottava, but said the team at Johnson & Johnson “weren’t quite ready.” His suggestion to stay tuned may point to more news soon as he remains optimistic for what Ottava may bring.

“I’m super excited about the next generation of surgery,” Buehler added.

Fast forward to our DeviceTalks West event in Santa Clara, California last month, and J&J MedTech’s company group chair for Robotics & Digital stood by the need for the company to create a soft-tissue surgical robotics system. Said Hani Abouhalka: “Talk to any surgeon, and they’ll say they need multiple players to come in and move this market forward.” When it comes to the challenges that J&J has faced, he said: “Robotics is hard. Robotics in healthcare is hard.”

Today, the company said it plans to submit Ottava for FDA investigational device exemption (IDE) in the second half of 2024 to initiate clinical trials.

“Johnson & Johnson was born in surgery with the advent of sterile sutures, and we have since helped surgeons improve care for patients by offering transformative technologies across all types of surgery,” Abouhalka said in a news release. “We believe the future of surgery is personal. Starting with the human impact – the connection between the patient, surgeon, and OR staff – we are unlocking what science and technology can do to improve the surgical experience and health outcomes for everyone involved. Ottava is designed to consistently deliver this experience in any OR globally.”

Johnson & Johnson provides more details on the Ottava system itself

In the initial unveiling of Ottava, the company highlighted its six-armed approach. It aimed to provide more control and flexibility in surgery, while those arms will be integrated into the operating table.

Today’s update shed more light on Ottava and some changes in its look over the past three years. The company said Ottava incorporates four robotic arms into a standard-size surgical table. Its unified architecture allows for an invisible design, J&J says. The robotic arms are available when needed and stowed beneath the surgical table when not.

“With Ottava, we intend to drive simplicity and new experiences through our unique architecture,” Rocco De Bernardis, global president, Ottava, told MassDevice.

Johnson & Johnson MedTech said the design removes barriers to movement and collaboration in robotic operating rooms. It also offers surgical teams the freedom and flexibility to adapt to clinical workflows and individualize patient needs.

“Ottava reimagines the surgical experience,” the company said in a news release. “The system is designed to create space in the operating room, simplify complex workflows, enable flexibility for clinical approaches, and deliver the trusted performance of Ethicon instrumentation”

The system also offers a “twin motion” feature, with the unified movement of the table and robotic arms. J&J designed it this way to allow surgical teams to address important clinical needs during surgery. That could include repositioning a patient without interrupting the procedure.

Johnson & Johnson says the Ethicon instruments used with Ottava are “backed by decades of innovation and market leadership in minimally invasive surgery.” They provide leading device-to-tissue and user-to-device interactions.

“I want consistency and reliability across the instruments I use,” said Dr. Erik Wilson, chief of minimally invasive and elective general surgery at the University of Texas Health Science Center in Houston. “Often today, I am required to use instruments with variable utility and functionality between traditional laparoscopic procedures and robotic-assisted procedures. Access to the reliable Ethicon laparoscopic instruments on a robotic platform would be useful to operate with less variability regardless of surgical modality.”

Editor’s Note: This article was syndicated from our sister publication MassDevice.

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