FDA clearance enables reuse of da Vinci Xi instruments, offering hospitals a new sourcing option.
Restore Robotics announced that Eugene Dickens, MD, FACS, at Hillcrest Medical Center in Tulsa, Okla, conducted the first-in-human use of a remanufactured da Vinci Xi robotic instrument on a patient using the newest model robotic surgical system, the da Vinci 5. In addition, Panama City Surgery Center performed the first-in-human use on a da Vinci Xi, which is the workhorse of the da Vinci robotics surgical systems.
Restore Robotics holds the only clearance from the US Food and Drug Administration (FDA) to remanufacture Xi robotic instruments, which are made available to hospitals through Encore Medical Device Repair, Restore Robotics’ commercial partner. With the clearance to remanufacture da Vinci Xi robotic monopolar scissors, Restore Robotics and Encore are offering hospitals and surgery centers a new option for sourcing robotic instruments beyond the original manufacturer.
“Our FDA clearance means that the remanufactured instrument is substantially equivalent to a new instrument,” says Clif Parker, CEO of Restore Robotics, in a release. “But the real-life use of the remanufactured instrument on a patient is the ultimate proof that our remanufactured instruments are safe and effective.”
Restore Robotics and Encore are launching their robotic remanufacturing program in large hospital systems across the country.
“I just had the chance to use the remanufactured Restore Robotics scissor. I have to say it worked perfectly. You couldn’t tell anything was different from a factory-fresh instrument. Knowing the instrument has been through 100% quality checks and calibration gave me the peace of mind to use it with confidence,” says Dickens in a release. “It is a great feeling to know I can deliver uncompromised quality to my patient at a reduced cost to the healthcare system. The environmental impact of using sustainable goods probably has the biggest impact globally and should not go without mention.”
Mike Madewell, CEO of Panama City Surgery Center, says in a release, “We have been purchasing certified pre-owned instruments from Restore for our da Vinci Xi robot, and when we used the remanufactured monopolar scissors, it performed just like a new instrument out of the box. There was no discernible difference between the Restore instrument and a new one.”
Restore Robotics is working on getting clearances for other da Vinci robotic instruments.
Photo caption: da Vinci XI instruments
Photo credit: Intuitive Surgical
