Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products, with an emphasis on serving the healthcare needs of women, today announced it received U.S. Food and Drug Administration (FDA) clearance for the Company's Single Energy (SE) Femur Exam on a dual energy x-ray absorptiometry (DXA) platform for the assessment of features associated with atypical femur fractures (AFF). This first-of-its-kind capability assists clinicians in their assessment of potential AFF in patients who have been on anti-resorptive treatments such as bisphosphonates.
The new assessment option will be offered exclusively on Hologic's Horizon DXA platform, a soon to be commercialized product line of bone densitometers. This quick 15-second SE Femur Exam is designed to produce a high resolution image of the entire femur with a very low effective radiation dose. An AFF assessment can be conveniently performed at the time of a hip bone density scan with little or no patient repositioning and a minimal increase in exam time.
"We developed our Single Energy Femur Exam in an effort to provide clinicians with the critical information needed to effectively manage patient care and improve fracture-related outcomes," said John Jenkins, Hologic Vice President of Marketing for Specialty Imaging Products. "An atypical femur fracture is an extremely debilitating fracture, in many instances much worse than a normal osteoporosis-related hip fracture. While these fractures are uncommon, the morbidity associated with them is significant. Recently published studies indicate that patients who suffer an AFF face extensive in-patient hospitalization, are at high risk for complications, and often report poorer health and function after the fracture.1 By including a convenient way for the physician to assess possible developing AFFs, early medical intervention may avoid the significant morbidity of a complete atypical femur fracture."
"The 2010 American Society for Bone and Mineral Research (ASBMR) Task Force on atypical femoral fracture emphasized that physicians should ask patients on bisphosphonates about thigh or groin pain, as this often precedes atypical femur fractures," comments Kevin Wilson, PhD, Hologic Scientific Director of Skeletal Health. "Further, the FDA has instructed physicians to evaluate any patients on bisphosphonates with thigh or groin pain to rule out a femoral fracture. Our SE Femur Exam is cleared by the FDA to visualize features associated with AFFs, and this can be done quickly and conveniently at the time of osteoporosis assessment."
1 Shkolnikova, J. et al. Burden of bisphosphonate-associated femoral fractures. ANZ J Surg 83. (2013) 175-181