With the Varjo headset you can do both virtual reality and augmented reality so it’s really the realization of what the ultimate device will be in the future, but it’s here now at the enterprise level,” he said. Stavros Alevrogiannis, medical director for the Metropolitan General Hospital in Athens, Greece, also believes that AR technologies will ring in a new era for orthopedic surgery.
Alevrogiannis, an expert in robotic knee and hip surgery, was the first surgeon in Greece to use Pixee Medical’s FDA-cleared total knee replacement surgery solution with Vuzix’s M400 Smart Glasses. The total knee arthroplasty solution aims to help orthopedic surgeons with the implant positioning with the use of AR glasses. Alevrogiannis noted that using an AR-driven solution offers several advantages over using robotic-assisted navigation. Most importantly, surgeons don’t need to use pins, which reduces the risk of potential complications such as infection, less trauma and also less radiation exposure to surgeons and patients. In addition, the “surgeon’s attention is not distracted from the surgical field [to look] at monitors,” which saves the surgeon time. But there are also drawbacks to AR. He noted that looking through AR glasses can be “dizzying” as surgeons’ eyes need to adjust to looking at the operating site while also looking at the data coming through the software. He commended Pixee for the software, but would like to see more improvements. He pointed out that the software cannot provide the surgeon with the exact size of the implant. It also cannot give surgeons the exact orientation of the tibial implant nor information about soft-tissue balancing, an important step in optimizing the mechanical balance of the knee joint – “which is not good,” he said. Despite these drawbacks, Alevrogiannis said he is very comfortable using Pixee’s software, pointing to his extensive experience doing knee replacements and added that “patients are quite satisfied.” Sebastian Henry, CEO of Pixee Medical, told Medtech Insight that the firm’s AR technology is “still compatible with current standard technique for sizing and software-tissue balancing. He said that working on data integration would have meant “more delays and the need of the implant manufacturer’s authorizations.”
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There are 17 implant manufacturers distributing Pixee’s product in Europe and Australia and they have the ability to integrate “new features including 3D implant visualization, sizing, rotation and soft-tissue balancing. He noted that proof of concept will be presented at the upcoming American Academy of Orthopeadic Surgeons (AAOS) conference to be held in San Diego from 31 August to 4 September. (Also see “Orthopedic Roundup Q1: COVID-19’s Stranglehold On Ortho Devices Begins To Loosen” – Medtech Insight, 17 May, 2021.) Pixee has sold more than 60 systems since it launched the product in early 2021 with requests “increasing every day,” Henry said. In the US, the firm is in talks with potential distribution partners, which he expects will lead to an agreement in the third quarter of 2021.
“We expect to perform first surgeries in the US before the AAOS [conference],” Henry said, adding that the firm has received requests from Hospital for Special Surgery (HSS) in New York, Massachusetts General Hospital in Boston and Johns Hopkins in Baltimore. Switzerland-based designer and supplier of orthopedics products, Medacta International SA was first in the US to receive FDA clearance for its NextAR surgical platform using Vuzix smart glass technology in July 2020. HSS orthopedic surgeon, Jonathan Vigdorchik, used the technology to perform the first AR-based total knee arthroplasty in the US last December. Paul Travers, Vuxiz CEO, said, “Vuzix Smart Glasses continue to be leveraged across health care to aid in the delivery of the next generation of clinical care such as surgeries that leverage augmented reality smart glasses, artificial intelligence and machine learning.”
Alevrogiannis foresees that in the future, AR smart glass makers will be acquisition targets for major orthopedic companies looking to integrate AR solutions into their robotic systems.