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 score: Jeff Pinette

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

The corporate first shared particulars on the Ottava surgical robotic platform practically three years in the past. It highlighted the potential for unmatched flexibility and management in comparison with the remainder of the market. The primary take a look at the surgical robotic marked a major step into the surgical robotic house dominated by Intuitive Surgical over the previous 20 years. J&J joined the listing of corporations, each giant and small, aiming to take Intuitive on within the soft-tissue robotics enviornment.

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 components. J&J initially anticipated to start the verification and validation processes for Ottava in 2021. The corporate deliberate for enrollment in medical trials for the machine in 2022 to comply with.

‘Keep tuned’

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

“Keep tuned,” he mentioned throughout a keynote presentation. “It’s taking place.”

Buehler hoped to supply a “massive reveal” on Ottava, however mentioned the workforce at Johnson & Johnson “weren’t fairly prepared.” His suggestion to remain tuned might level to extra information quickly as he stays optimistic for what Ottava might convey.

“I’m tremendous excited in regards to the subsequent era of surgical procedure,” Buehler added.

Quick 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. Mentioned Hani Abouhalka: “Discuss to any surgeon, and so they’ll say they want a number of gamers to return in and transfer this market ahead.” In the case of the challenges that J&J has confronted, he mentioned: “Robotics is difficult. Robotics in healthcare is difficult.”

Right this moment, the corporate mentioned it plans to submit Ottava for FDA investigational machine exemption (IDE) within the second half of 2024 to provoke medical trials.

“Johnson & Johnson was born in surgical procedure with the appearance of sterile sutures, and now we have since helped surgeons enhance look after sufferers by providing transformative applied sciences throughout all forms of surgical procedure,” Abouhalka mentioned in a information launch. “We consider the way forward for surgical procedure is private. Beginning with the human impression – the connection between the affected person, surgeon, and OR workers – we’re unlocking what science and expertise can do to enhance the surgical expertise and well being outcomes for everybody concerned. Ottava is designed to constantly ship this expertise in any OR globally.” 

Johnson & Johnson offers extra particulars on the Ottava system itself

Within 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.

Right this moment’s replace shed extra gentle on Ottava and a few modifications in its look over the previous three years. The corporate 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 via our distinctive structure,” Rocco De Bernardis, world president, Ottava, advised MassDevice.

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

“Ottava reimagines the surgical expertise,” the corporate mentioned in a information launch. “The system is designed to create house within the working room, simplify complicated workflows, allow flexibility for medical approaches, and ship the trusted efficiency of Ethicon instrumentation”

The system additionally gives a “twin movement” characteristic, with the unified motion of the desk and robotic arms. J&J designed it this technique to permit surgical groups to handle vital medical wants throughout surgical procedure. That would embody repositioning a affected person with out interrupting the process.

Johnson & Johnson says the Ethicon devices used with Ottava are “backed by many years of innovation and market management in minimally invasive surgical procedure.” They supply main device-to-tissue and user-to-device interactions.

“I need consistency and reliability throughout the devices I take advantage of,” mentioned Dr. Erik Wilson, chief of minimally invasive and elective common surgical procedure on the College of Texas Well being Science Middle in Houston. “Usually right now, I’m required to make use of devices with variable utility and performance between conventional laparoscopic procedures and robotic-assisted procedures. Entry to the dependable Ethicon laparoscopic devices on a robotic platform can be helpful to function with much less variability no matter surgical modality.” 

Editor’s Observe: This text was syndicated from our sister publication MassDevice

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