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Johnson & Johnson MedTech (NYSE: JNJ) at present 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 unequalled flexibility and management in comparison with the remainder of the market. The primary have a look at the surgical robotic marked a big step into the surgical robotic area dominated by Intuitive Surgical over the previous twenty years. J&J joined the listing of corporations, each massive 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 as a result of 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 machine in 2022 to comply with.
‘Keep tuned’
“Keep tuned,” he stated throughout a keynote presentation. “It’s occurring.”
Buehler hoped to supply a “massive reveal” on Ottava, however stated the staff at Johnson & Johnson “weren’t fairly prepared.” His suggestion to remain tuned could level to extra information quickly as he stays optimistic for what Ottava could convey.
“I’m tremendous excited concerning 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.” Relating to the challenges that J&J has confronted, he stated: “Robotics is tough. Robotics in healthcare is tough.”
Right this moment, the corporate stated it plans to submit Ottava for FDA investigational machine exemption (IDE) within the second half of 2024 to provoke scientific trials.
“Johnson & Johnson was born in surgical procedure with the appearance of sterile sutures, and we’ve since helped surgeons enhance take care of sufferers by providing transformative applied sciences throughout all kinds 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 employees – we’re unlocking what science and know-how 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 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 adaptability in surgical procedure, whereas these arms will probably 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 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, international president, Ottava, instructed MassDevice.
Johnson & Johnson MedTech stated the design removes limitations to motion and collaboration in robotic working rooms. It additionally provides surgical groups the liberty and adaptability 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 area within the working room, simplify complicated workflows, allow flexibility for scientific approaches, and ship the trusted efficiency of Ethicon instrumentation”
The system additionally provides a “twin movement” characteristic, with the unified motion of the desk and robotic arms. J&J designed it this option to enable surgical groups to deal with necessary scientific wants throughout surgical procedure. That might embrace 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 normal surgical procedure on the College of Texas Well being Science Heart in Houston. “Typically at present, 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
Editor’s Observe: This text was syndicated from our sister publication MassDevice.