Friday, December 8, 2023

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


Hearken to this text

Voiced by Amazon Polly
martin buehler.

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

Johnson & Johnson MedTech (NYSE: JNJ) immediately 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 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 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 consequence of a number of elements. 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’

On the Robotics Summit & Expo in Might, 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 offer a “massive reveal” on Ottava, however mentioned the crew 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 deliver.

“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: “Speak to any surgeon, and so they’ll say they want a number of gamers to come back in and transfer this market ahead.” On the subject of the challenges that J&J has confronted, he mentioned: “Robotics is tough. Robotics in healthcare is tough.”

As we speak, the corporate mentioned 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 arrival 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 imagine the way forward for surgical procedure is private. Beginning with the human influence – the connection between the affected person, surgeon, and OR workers – 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 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 might be built-in into the working desk.

As we speak’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 by way of our distinctive structure,” Rocco De Bernardis, world president, Ottava, informed MassDevice.

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

“Ottava reimagines the surgical expertise,” the corporate mentioned in a information launch. “The system is designed to create area within the working room, simplify advanced 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 method to enable surgical groups to handle vital 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 many years 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 exploit,” mentioned Dr. Erik Wilson, chief of minimally invasive and elective basic surgical procedure on the College of Texas Well being Science Middle in Houston. “Typically immediately, 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 could be helpful to function with much less variability no matter surgical modality.” 

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


Related Articles

Latest Articles