Amsterdam, The Netherlands, September 01, 2017 / B3C newswire / -- Sigmascreening, a Dutch MedTech developer and world leader in the field of pressure based digital mammography and breast cancer screening, announces that a study of in total 15,898 in digital mammograms from 3,772 Asian women(1), underlines the need for compression guidelines. The study confirms a number of other studies indicating that a force-standardized protocol leads to large variations in compression practices. This has serious negative effects on patient experience and the efficacy of mammography, one of the most commonly used diagnostic screening tools throughout the world. Therefore pressure guided mammography with the Sigma™ Paddle, which is taking breast size into account, may lead to improved test results and less unnecessary discomfort and pain especially for Asian women.
In a mammographic examination, the breast is compressed four times. The importance of this study is that it clarifies that Asian women, who generally have smaller breasts, are subject to force standardized protocols originally intended for Caucasian women. For that reason the researchers retrospectively analyzed the digital mammograms from Asian women. The mean ± standard deviation compression pressure for all mammograms was 17.77±10.51 kPa, which indicates a very unpredictable outcome of the compression procedure in these women.
This study showed that in particular a force-standardized mammographic compression practice led to these widely variable compression parameters with a substantial amount of excessively high pressures without the use of the Sensitive Sigma paddle. These results are in line with compression practice in other Asian countries(2).
Monique van Lier, Clinical Application Scientist at Sigmascreening comments: “If the Sensitive Sigma™ Paddle would be used in Asia, we expect better breast compression, which could improve specificity (true positives) of tumor detection and at the same time preventing unnecessary discomfort and pain, which may contribute to a higher breast cancer screening compliance of women as well. In other words, the use of our technology protects especially women with smaller breasts against excessive high compression pressures while potentially improving the results of the test ”.
This study underpins the importance of taking breast size into account and is in accordance with Sigmascreening’s concept of the Sensitive Sigma™ Paddle, which applies pressure guidance during mammography. The Sensitive Sigma™ Paddle is the first pressure based compression paddle providing real-time pressure information of the whole mammographic breast compression course, which can considerably improve compression reproducibility aiming at an evidence based pressure target; similar for all women .
As a result of this, extremely high or low pressures, as observed in this study, will disappear almost entirely by the use of the Sensitive Sigma™ paddle. It optimizes compression for every individual breast, by taking breast size and stiffness into account, for the most optimal screening result while reducing unnecessary and often extreme pain.
Rapid market acceptance in Europe
Sigmascreening’s pressure-standardized breast compression is expanding rapidly in screening centers and hospitals throughout Europe. In Europe, over 10,000 patients already experienced the more woman-friendly way of making mammograms while clinicians are starting to recognize the improved sensitivity and specificity of our technology. The Sensitive Sigma™ Paddle with CE marking is already being used in the United Kingdom, Norway, France, Germany, Sweden, The Netherlands, Belgium and Switzerland.
Sigmascreening, founded in 2009, is an Amsterdam based MedTech company focusing on the development of new innovative products in the area of digital mammography and breast cancer screening. The Sensitive Sigma™ Paddle is the first product with CE marking, based on patented technology. Sigmascreening aims to further introduce new products that will improve mammography and contribute to the early detection of cancer, which ultimately can save lives.
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(1) Lau, S., Y. F. Abdul Aziz and K. H. Ng (2017). "Mammographic compression in Asian women." PLoS One 12(4): e0175781
(2) Ng, K. H., M. L. Mill, L. Johnston, R. Highnam and A. Tomal (2017). "Large variation in mammography compression internationally". EPOStm C-2133, ECR 2017.