Exposure to radiation during fluoroscopically guided procedures is of grave concern to patients and providers. Imagine reducing that exposure by 89%.
On May 22, 2019, ControlRad, Inc., announced FDA 510(k) clearance of its ControlRad Trace. The company says its device “is the only technology that can be integrated into existing mobile C-arms to reduce radiation during fluoroscoping imaging procedures.”
Further, the company claims the ControlRad Trace can “reduce unnecessary radiation up to 89%, without compromising image quality in the region of interest (ROI) and overall workflow.”
This is accomplished by drawing the ROI on a ControlRad tablet, “which in real-time optimizes image quality in the ROI while reducing unnecessary radiation in the periphery.” The system has a proprietary semi-transparent filter, tablet and image processing technology which is retrofitted on existing C-arms.
“With over 17 million fluoroscopic procedures in the U.S. every year, the ControlRad Trace is the only system available that can impact all of them,” said Chris Fair, ControlRad executive vice president and president, Mobile C-arm division. “Regardless if it is a pain management treatment, an orthopedic trauma case or even a minimally invasive spine procedure, our technology will reduce radiation exposure and protect those who are saving the lives of others.”
C-arms expose patients and medical staff to ionizing radiation. The company cites evidence that the radiation which may increase a person’s lifetime risk of developing cancer. For example, an interventional fluoroscopy procedure is roughly equivalent to the adult effective dose of between 250-3,500 chest X-rays.
ControlRad Trace Model 8
Here is how the FDA summary letter describes the device:
The ControlRad™ Trace Model 8 (Trace) is an accessory to the cleared OEC9800/OEC9800 Plus (Plus) system. The Trace accessory installed in the Plus is a system used to assist trained clinicians. The system is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians’ radiation exposure (Dose Area Product) outside of the Trace’s region of interest (ROI) as compared to the Plus non-collimated image area. The Trace can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.
The summary letter cautions that Trace’s semi-transparent filter should not be used in lieu of the Plus’s collimators,”as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI.”
John Carrino, M.D., M.P.H., vice chairman of Radiology, Hospital for Special Surgery, said the new technology “has the potential to drastically improve our radiation safety while maintaining image quality so we can continue to effectively diagnose and treat our patients. I believe these new products should become the standard of care for fluoroscopic procedures.”
ControlRad is headquartered in Atlanta, Georgia, and has engineering development facilities in Kfar Saba, Israel.
