ControlRad has announced the first clinical use of the ControlRad Trace system following its clearance by the US Food and Drug Administration. The initial procedures were performed at Niagara Falls Memorial Medical Center (Niagara Falls, USA) by Andrew Cappuccino, an orthopaedic surgeon specialising in minimally invasive spine surgery.
“The ControlRad Trace system exceeded my expectations in reducing my radiation exposure, as well as the exposure to my patient and to my operating room team,” Cappuccino said. “There was no interruption of my normal workflow and zero loss to my image quality in the area where I was focused. As a surgeon who was diagnosed with leukemia after many years of performing fluoroscopically guided minimally invasive spine procedures, I believe ControlRad Trace to be groundbreaking and one of the most important safety innovations that has been brought to market during my tenure as a surgeon.”
FGPs with C-arms have allowed for major advances in treating countless diseases; however, they expose patients and medical staff to ionising radiation, which may increase a person’s lifetime risk of developing cancer. The ControlRad Trace solution is the only technology that can be integrated into existing mobile C-arms to reduce radiation in any FGP. The ControlRad Trace system reduces radiation exposure by up to 89%, protecting patients and medical staff without compromising image quality or workflow.
“We are extremely pleased that the ControlRad Trace system is now being used clinically, seamlessly reducing radiation exposure to the patient and to the operating room team,” says Guillaume Bailliard, ControlRad chief executive officer. “It is humbling to be able to play a valuable role in providing a safer environment to the medical staff who are day-in, day-out putting themselves in harm’s way in order to treat their patients.”
With its proprietary semi-transparent filter, tablet and image processing technology, the ControlRad Trace solution can be retrofitted on existing C-arms, reducing the barrier to adopting the technology. The ControlRad Trace system reduces unnecessary radiation, protecting patients and medical staff without compromising image quality in the region of interest and overall workflow. The medical staff draws a region of interest (ROI) on a ControlRad tablet, which in real-time optimises image quality in the ROI while reducing unnecessary radiation in the periphery.
“Radiation from C-arm procedures may increase the risk of brain cancer, cataracts, strokes and atherosclerosis, and with over 17 million fluoroscopic procedures in the USA every year, the ControlRad Trace is the only system available that can be utilised in each one,” says Chris Fair, ControlRad executive vice president and president, Mobile C-arm division. “Regardless of whether it is a spine or orthopedic procedure, pain management or urology case, our technology reduces radiation exposure and protects those who are saving the lives of others, like Dr Cappuccino.”