Reducing X-ray Exposure during fluoroscopy-guided medical procedures.
Building on strengths in medical physics and technology, AAPS facilitated the formation of a company dedicated to reducing radiation exposure during fluoroscopy-guided medical procedures.
Many people are familiar with heart stent medical procedures. In fact, U.S. President Bill Clinton had a stent procedure performed in February 2010. Tens of thousands of these procedures are performed each year in Canada alone.
The stent is typically a small tube that is placed within a coronary artery to expand the vessel and permanently displace a blockage (for instance, due to plaque). Insertion and installation of a stent is a minimally invasive procedure because the stent is fed in through an artery elsewhere in the body and gently guided to its final destination around the heart muscle.
Inserting a stent is bit like finding your way through a maze and the interventional cardiologists who perform the procedure are exceptionally well-trained and experienced. One of the tools used in this procedure is fluoroscopy—a technology that takes a high-resolution x-ray image of the body multiple times per second to give the doctor nearly real-time feedback on the procedure. Fluoroscopy is also used in other minimally invasive medical procedures such as vascular applications, neurological studies, or electro-physiology.
There is an unintended consequence of fluoroscopic imaging: both the patient and doctor receive appreciable levels of X-ray radiation during the procedure, which can sometimes take hours. Strategies to reduce this side effect have been discussed and studied for at least a decade. Radiation-induced heath risks in patients undergoing fluoroscopy, such as skin burns, have been recognized for many years. Furthermore, medical staff performing fluoroscopy have been prone to back-related injuries from prolonged use of heavy lead aprons to protect themselves from radiation exposure. Recent research of fluoroscopy procedures has also demonstrated an increased risk of radiation-induced cataracts for medical staff and cancer in patients, promoting discussion on occupational hazards and better regulatory mandates in fluoroscopic procedures.
By introducing a fast-moving shutter system and integrated image processing software, X-ray exposure can be significantly reduced. The system is designed to maintain image quality in the region-of-interest to the physician, while reducing exposure in the broader field of view. The successful development of the technology will reduce X-ray exposure for both patients and medical staff by up to tenfold. In addition, it could also open the door to longer and more sophisticated procedures.
Manufacturers of fluoroscopy imaging equipment continually strive to improve their products and are expected to integrate this technology into their systems as part of their commitment to keeping X-ray exposure rates as low as reasonably achievable.
During 2010-2011, AAPS provided financing to help fast-track the formation of a new company dedicated to bringing this technology to commercial fruition: IKOMED Technologies, Inc. In June 2011, IKOMED secured its first round of funding. This round enables IKOMED to develop and test its technology for fluoroscopy radiation reduction. In July, IKOMED was granted the first of a series of patents by the U.S. Patent and Trademark Office and establish IKOMED’s intellectual-property position. IKOMED has now developed several prototypes of the lead-shutter technology and the computerized control systems.
IKOMED has been collaborating with several leading medical imaging vendors, and has successfully performed integration of the shutter system with their clinical Fluoroscopy equipment. Clinical demonstration of an integrated solution was successfully performed on animals, at a Vancouver hospital, demonstrating the anticipated radiation reduction and validating the practicality of the system. Additional clinical trials have demonstrated the performance and applicability of IKOMED’s automatic software that tracks the region-of-interest in coronary human interventions. It is anticipated that a fully integrated IKOMED system will be tested on humans in 2016 and released to market. IKOMED intends to manufacture its products in BC and forecasts annual revenues of several million dollars by 2018.
IKOMED holds 5 granted US patents and has filed 10 additional patent applications.