Johnson & Johnson plans to submit Ottava surgical robotic for FDA IDE subsequent 12 months

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

Johnson & Johnson MedTech (NYSE: JNJ) right now outlined its plan to submit its new Ottava surgical robotic to the FDA.

The firm first shared particulars on the Ottava surgical robotic platform almost three years in the past. It highlighted the potential for unequalled flexibility and management in comparison with the remainder of the market. The first take a look at the surgical robotic marked a major step into the surgical robotic area dominated by Intuitive Surgical over the previous twenty years. J&J joined the record of firms, each giant and small, aiming to take Intuitive on within the soft-tissue robotics area.

Since that day in November 2020, Johnson & Johnson MedTech has remained quiet on the subject, although. In October 2021, it pushed again the platform’s improvement timeline by about two years resulting from a number of elements. J&J initially anticipated to start the verification and validation processes for Ottava in 2021. The firm deliberate for enrollment in scientific trials for the system in 2022 to comply with.

‘Stay tuned’

At the Robotics Summit & Expo in May, Martin Buehler, world head of robotics R&D, gave the final replace on Ottava.

“Stay tuned,” he mentioned throughout a keynote presentation. “It’s happening.”

Buehler hoped to offer a “big reveal” on Ottava, however mentioned the crew at Johnson & Johnson “weren’t quite ready.” His suggestion to remain tuned might level to extra information quickly as he stays optimistic for what Ottava might carry.

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

Fast ahead to our DeviceTalks West occasion in Santa Clara, California final month, and J&J MedTech’s firm group chair for Robotics & Digital stood by the necessity for the corporate 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 involves the challenges that J&J has confronted, he mentioned: “Robotics is hard. Robotics in healthcare is hard.”

Today, the corporate mentioned it plans to submit Ottava for FDA investigational system exemption (IDE) within the second half of 2024 to provoke scientific 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 mentioned in a information launch. “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 offers extra particulars on the Ottava system itself

In the preliminary unveiling of Ottava, the corporate highlighted its six-armed strategy. It aimed to present extra management and suppleness in surgical procedure, whereas these arms can be built-in into the working desk.

Today’s replace shed extra gentle on Ottava and a few adjustments in its look over the previous three years. The firm mentioned Ottava incorporates 4 robotic arms right into a standard-size surgical desk. Its unified structure permits for an invisible design, J&J says. The robotic arms can be found when wanted and stowed beneath the surgical desk when not.

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

Johnson & Johnson MedTech mentioned the design removes boundaries to motion and collaboration in robotic working rooms. It additionally affords surgical groups the liberty and suppleness to adapt to scientific workflows and individualize affected person wants.

“Ottava reimagines the surgical experience,” the corporate mentioned in a information launch. “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 additionally affords a “twin motion” characteristic, with the unified motion of the desk and robotic arms. J&J designed it this approach to enable surgical groups to deal with vital scientific wants throughout surgical procedure. That may embrace repositioning a affected person with out interrupting the process.

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

“I want consistency and reliability across the instruments I use,” mentioned Dr. Erik Wilson, chief of minimally invasive and elective common surgical procedure on 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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