PHILADELPHIA, PA – March 31, 2016 – ControlRad announced that definitive results from an in vivo evaluation of its proprietary solution to considerably reduce patient and medical staff exposure to ionizing radiation during fluoroscopically guided interventional procedures (FGIP) have been published in the peer-reviewed journal Medical Physics. 1
The published study demonstrated that use of the ControlRad technology reduced the radiation dose exposure to the patient and operators by approximately 75 percent, without interfering with the performance of the procedure. They also found that the radiation reducing technique produced a subjective enhancement of perceived visualization. Study authors included investigators from Columbia University, Mt. Sinai Hospital, CRF Skirball Center for Innovation, and the University of Pennsylvania.
“The risks of radiation exposure during interventional X-ray procedures to both patients and the medical staff are well documented,” said Stephen Balter, Ph.D., Departments of Radiology and Medicine, Columbia University, and lead author of the study. “These results demonstrate a novel approach to dramatically reducing the radiation exposure by allowing the operator to optimize the X-ray beam using eye-tracking, without compromising either image quality or workflow.”
In the study, three types of paired interventional procedures were performed on swine using a mobile c-arm with the ControlRad technology. When the ControlRad technology was engaged, the subject and operator irradiation was decreased by approximately 75% as measured by multiple radiation measuring devices, including KAP (Kerma Area Product). Eye-tracking technology allowed the operator’s gaze to dynamically define the region of interest throughout the procedure and optimize the X-ray beam for highest imaging resolution in the area being directly examined. Measurements of the amount of radiation delivered to both the subjects and the operators were taken with and without the ControlRad technology engaged.
“The impressive study results provide important validation of the clinical utility and potential benefits of our technology,” said Guillaume Bailliard, President and CEO of ControlRad. “By allowing the operator seamless control of the X-ray beam, we are able to optimize it in the region of immediate clinical interest not only substantially reducing the radiation dose delivered to the patient but also dramatically reducing the lifetime radiation exposure to the medical staff.”
About Radiation Risks Associated with Fluoroscopically Guided Interventional Procedures
Fluoroscopic imaging, utilizing continuous X-ray radiation to provide real-time visualization of internal structures of the body, remains an essential component of life-saving, minimallyinvasive interventional procedures. In the United States, there are approximately 7,000 fixed carms in use by cardiologists, radiologists and vascular surgeons and 25,000 mobile c-arms utilized by orthopedic surgeons, pain management physicians, vascular surgeons, urologists, gastroenterologists, and pulmonologists. Despite a variety of precautions, physicians and medical staff using this equipment during interventional procedures are exposed to levels of radiation over time that are orders of magnitude higher than other healthcare professionals and the general public. This excessive lifetime exposure to radiation is recognized as a serious problem with well-documented health risks, including increased incidence of cataracts, stroke and disproportionate rates of atherosclerosis and possibly cancer.
ControlRad is a privately-held medical technology company developing innovative products that dramatically reduce the lifetime risk of radiation exposure from fluoroscopically guided interventional procedures (FGIP) for patients and healthcare professionals. These products are designed to improve safety without compromising image quality or workflow. This is accomplished with an integrated set of proprietary components which optimize the X-ray beam to deliver optimal image quality in the clinically-relevant region of focus of the physician while maintaining appropriate resolution in the periphery. ControlRad is headquartered in Philadelphia and has engineering development facilities in Kfar Saba, Israel. For more information, visit www.controlrad.com.
1 Balter S, Simon D, Itkin M, Granada JF, Melman H, Dangas G. Significant radiation reduction in interventional fluoroscopy using a novel eye controlled movable region of interest. Med Phys 43 (3) March, 2016: 1531‐1538.