- Fovia Ai
CHICAGO, Nov. 27, 2018 /PRNewswire/ -- Sigmascreening will showcase its Sensitive Sigma™ Paddle, which enables personalized compression for better quality mammograms without unnecessary discomfort for patients, at the upcoming 103rd Annual Radiological Society of North America (RSNA) meeting, November 26-December 1, 2017. (South Hall #3179).
Each year, an estimated 125 million women throughout the world are imaged using mammography. To get the best image quality during a mammogram with the least amount of radiation, the breast needs to be flattened. This is done by compressing the breast. Under-compression can lead to blurred images, more retakes and a higher average glandular dose (AGD), while over-compression causes discomfort and unnecessary pain for the patient.
Based on breast-size and tissue-stiffness the Sensitive Sigma Paddle calculates the pressure to achieve an optimal compression of 75mmHg and allows for a highly reproducible procedure. The patented Sensitive Sigma Paddle has multiple sensors that measure each breast to optimize compression for each breast. The Sensitive Sigma Paddle is the first pressure-based compression paddle in the market which provides this pressure information real-time.
Recently published studies bolster the growing body of research that demonstrates the impact of pressure in breast compression on screening performance and the ability for the Sensitive Sigma Paddle, with its intermediate target pressure, to improve detection rates and patient satisfaction.
The study "Mammographic compression in Asian women,"published recently in PLoS One, showed that a force-standardized mammographic compression practice led to widely variable compression parameters in Asian women. These force-standardized protocols have largely been optimized for Caucasian women and might not be suitable for Asian women, who generally have smaller breasts. Therefore pressure-guided mammography with the Sensitive Sigma Paddle, which takes breast size into account, may lead to improved results and less discomfort and pain.
The study, "Is breast compression associated with breast cancer detection and other early performance measures in a population-based breast cancer screening program?" was recently published in Breast Cancer Research and Treatment (DOI: 10.1007/s10549-017-4214-8). The study evaluated the impact of compression pressure and force on performance measures; including recall rate, rates of screen-detected and interval breast cancers, positive predictive value of recall (PPV), sensitivity, and specificity. Researchers extracted compression force information and calculated pressure from DICOM-images on 261,641 mammographic examinations. As compression force increased, the recall rate decreased, while PPV and specificity increased. The recall rate increased, while rate of screen-detected cancer, PPV, sensitivity, and specificity decreased with increasing compression pressure. Results indicate that high compression force and low compression pressure provided more favorable performance measures, compared to low compression force and high compression pressure.
Investigational in the United States, the Sensitive Sigma Paddle is CE-marked and is being used at breast screening centers and hospitals in multiple countries in Europe. Since receiving CE-mark last year, more than 20,000 women have experienced the more convenient pressure-based compression paddle.
"We have seen use and adoption of the Sigma Paddle continue to increase based on the ability to improve both the quality of mammograms, as well as the patient experience," said Ivo Aarninkhof, CEO, Sigmascreening. "Personalised compression enabled by the Sigma Paddle adapts the compression to the individual size and shape of the patient's breast, which when explained to the patient, greatly reduces concerns about pain. Not only does this make the exam protocol faster, it improves quality and compliance for repeat exams."
Sigmascreening is a medical device company focusing on the development of new innovative products in the area of digital mammography and breast cancer screening. The Sensitive Sigma™ Paddle is our CE-certified product, based on our patented technology preventing over- and under-compression. We aim to introduce new products that will improve mammography and contribute to the early detection of cancer which ultimately can save lives.
Chris K. Joseph