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


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

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

The corporate 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 primary have 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 checklist of firms, 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 growth 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 scientific trials for the gadget 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 stated throughout a keynote presentation. “It’s occurring.”

Buehler hoped to offer a “large reveal” on Ottava, however stated the staff 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 carry.

“I’m tremendous excited concerning the subsequent technology 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. Stated Hani Abouhalka: “Speak to any surgeon, they usually’ll say they want a number of gamers to come back in and transfer this market ahead.” With regards to the challenges that J&J has confronted, he stated: “Robotics is tough. Robotics in healthcare is tough.”

At this time, the corporate stated it plans to submit Ottava for FDA investigational gadget exemption (IDE) within the second half of 2024 to provoke scientific trials.

“Johnson & Johnson was born in surgical procedure with the arrival of sterile sutures, and we have now since helped surgeons enhance look after sufferers by providing transformative applied sciences throughout all varieties of surgical procedure,” Abouhalka stated in a information launch. “We consider the way forward for surgical procedure is private. Beginning with the human affect – 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 persistently ship this expertise in any OR globally.” 

Johnson & Johnson supplies 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 will likely be built-in into the working desk.

At this time’s replace shed extra mild on Ottava and a few modifications in its look over the previous three years. The corporate stated 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 by our distinctive structure,” Rocco De Bernardis, world president, Ottava, advised MassDevice.

Johnson & Johnson MedTech stated the design removes obstacles 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 expertise,” the corporate stated in a information launch. “The system is designed to create house within the working room, simplify advanced workflows, allow flexibility for scientific approaches, and ship the trusted efficiency of Ethicon instrumentation”

The system additionally affords a “twin movement” characteristic, with the unified motion of the desk and robotic arms. J&J designed it this approach to enable surgical groups to deal with essential scientific wants throughout surgical procedure. That might embody repositioning a affected person with out interrupting the process.

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

“I would like consistency and reliability throughout the devices I take advantage of,” stated Dr. Erik Wilson, chief of minimally invasive and elective common surgical procedure on the College of Texas Well being Science Heart in Houston. “Usually in the present day, 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 Notice: This text was syndicated from our sister publication MassDevice

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