FDA authorization permits the study but not approval of the system
Dr Vipul Patel, founder and medical director of the Global Robotics Institute at AdventHealth Celebration in suburban Orlando, performed an investigational robotic prostatectomy on Sunday. The patient was at an AdventHealth facility in Minneola, Florida, while Patel operated remotely from another AdventHealth facility in the community of Celebration, 35 miles away, according to the AdventHealth news release. The procedure was part of a clinical research study evaluating a robotic telesurgery system.
The patient, identified as Mark, had volunteered for the clinical study. Marcio Moschovas, a study co-principal investigator and surgeon, provided on-site support during the procedure. AdventHealth told ABC that Mark was recovering well after the operation.
The surgery was conducted under an investigational device exemption approved by the Food and Drug Administration. AdventHealth said that authorization permits the system to be studied but does not constitute FDA approval or clearance.
The Florida operation came after 10 investigational telesurgeries between Orlando, Florida, and Luanda, Angola, and marked the study’s expansion into US hospitals, AdventHealth said.
AdventHealth’s release included a statement attributed to Patel: “For generations, access to highly specialized care has often depended on where a patient lives.” The statement added: “This study allows us to evaluate whether telesurgery could one day help reduce geographic barriers to specialized treatment.”
Telesurgery allows surgeons to control robotic instruments remotely, but researchers are still evaluating its safety, reliability and cybersecurity. AdventHealth said no previous reports had documented a telerobotic procedure between two US locations and described Sunday’s surgery as the first between two US hospitals.
The procedure carried the risks of robotic prostatectomy, including bleeding, infection, incontinence and erectile dysfunction, as well as the possibility of switching to open surgery. Telesurgery added the risk of equipment or connection failures and cybersecurity threats, making an on-site team essential to take over if needed.
Months earlier, a surgeon in London used a four-armed robot equipped with a 3D camera to remove a man’s prostate in Gibraltar, about 1,500 miles away. The London-Gibraltar surgery was successful, with a reported lag of just 0.06 seconds between the surgeon’s movements and the robot’s response.
Mark was recovering well after the Florida procedure, according to AdventHealth. The operation was part of an ongoing clinical study, and AdventHealth cautioned that it did not establish the technology’s general clinical performance; safety, reliability and cybersecurity remain under evaluation.