September 26, 2017 — Hologic Inc. announced the commercial availability of its new SmartCurve breast stabilization system, which has been clinically proven to deliver a more comfortable mammogram without compromising image quality, workflow or dose, according to the company.1 The SmartCurve system is available exclusively with Hologic's Genius 3-D Mammography exam, which detects more invasive breast cancers, reduces false positives, and is U.S. Food and Drug Administration (FDA)-approved as superior to conventional 2-D mammography for all women, including those with dense breasts, according to Hologic.2,3,4
For years, women have reported avoiding regular mammograms due in large part to the fear of discomfort associated with breast compression. In fact, a recent survey of 10,000 women found that fear of physical discomfort was the top reason cited for avoiding a mammogram by women who never had one.5
Breast pain experienced during a mammogram is directly related to the time spent under compression and the pressure distribution on the breast, two factors that must be addressed to improve the mammography experience. The SmartCurve system features a proprietary curved surface that mirrors the shape of a woman's breast to reduce pinching and allow better distribution of force over the entire breast. The system also features proprietary image processing algorithms that ensure the preservation of image quality and accuracy.
In a recent clinical study comparing the SmartCurve breast stabilization system to traditional flat paddle compression, the SmartCurve system improved comfort in 93 percent of women who reported moderate to severe discomfort with standard compression. In addition, 95 percent of those surveyed would recommend facilities that use the system.1 The system includes options to accommodate a majority of women and breast sizes, and can be used with Hologic's MammoPad breast cushion for even greater comfort.6
In addition, the SmartCurve system's image processing algorithm ensures there is no change in positioning or workflow for radiologists and technologists administering the breast imaging exam. Clinicians can feel confident they are offering patients an improved experience while maintaining efficiency within their facilities.
The SmartCurve system is available standard on Hologic's new 3Dimensions mammography system and as an enhancement option to existing Hologic Selenia Dimensions systems.
For more information: www.hologic.com
1. Smith, A. Improving Patient Comfort in Mammography. Hologic WP-00119 Rev 001 (2017).
2. Results from Friedewald, SM, et al. "Breast cancer screening using tomosynthesis in combination with digital mammography." JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia Dimensions on screening outcomes. Individual results may vary. The study found an average 41% (95% CI: 20-65%) increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2-D FFDM and 3-D mammograms acquired with the Hologic 3-D Mammography system versus women receiving 2-D FFDM mammograms only.
3. Bernardi D, Macaskill P, Pellegrini M, et. al. Breast cancer screening with tomosynthesis (3-D mammography) with acquired or synthetic 2-D mammography compared with 2-D mammography alone (STORM-2): a population-based prospective study. Lancet Oncol. 2016 Aug;17(8):1105-13.
4. U.S. Food & Drug Administration Premarket Approval (PMA). FDA.gov https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P080... June 5, 2017.
5. Kadence International, Ten Thousand Quantitative Findings Research Study (5107), April 2017.
6. Coryell T. Increasing Mammography Tissue Acquisition through Positioning Training and Use of a Foam Breast Cushion. National Consortium of Breast Centers, 16th Annual National Interdisciplinary Breast Conference, Las Vegas, NV (2006)