Sigmascreening to Introduce Sensitive Sigma Paddle at RSNA

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Pressure-based Compression Helps Solve the Under- and Over-Compression Problem and Enables Technologists to Perform Highly Reproducible Mammograms

Sensitive Sigma Paddle

The Sensitive Sigma Paddle makes it possible to incorporate additional parameters in the process like breast size and tissue stiffness during positioning, which enables mammograms to be standardized by compression pressure.

Sigmascreening will introduce the Sensitive Sigma Paddle, which enables personalized compression for better quality mammograms without unnecessary discomfort for patients, at the upcoming 102nd Annual Radiological Society of North America (RSNA) meeting, November 27-December 2, 2016. (North Hall #8417)

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. British research estimates that up to 20% of screening-eligible women worldwide decide not to have a mammogram because of the pain. This can decrease the rate of early detection, and delay medical treatment of tumors, thus decreasing women's chances of survival.

“A small breast requires significantly less force to compress than a larger breast. However, current guidelines still advise to standardize a target compression based on force, regardless of breast size,” said Ivo Aarninkhof, CEO, Sigmascreening. “The Sensitive Sigma Paddle makes it possible to incorporate additional parameters in the process like breast size and tissue stiffness during positioning, which enables mammograms to be standardized by compression pressure. The advantage of pressure-based compression is that it helps solve the problem of under- and over-compression and enables technologists to perform a highly reproducible procedure, year after year.”

The patented Sensitive Sigma Paddle has multiple sensors that measure each breast to optimize compression for each breast. 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 Sensitive Sigma Paddle is the first pressure-based compression paddle in the market which provides this pressure information real-time.

Investigational in the United States, the Sensitive Sigma Paddle is CE-marked and is actively being used at breast screening centers and hospitals in England, Germany, Sweden, The Netherlands, Belgium and Switzerland. Since receiving CE-mark last year, more than 10,000 women have experienced the more convenient pressure-based compression paddle.

The relationship between pressure applied during compression of the breast and screening performance was recently investigated in the study “Performance of breast screening and cancer detection depends on mammography compression,” which was presented at the 13th International Workshop of Mammographic Imaging in Malmö, June 2016, and published in Breast Imaging (DOI: 10.1007/978-3-319-41546-8_24). Researchers computed the compression pressure applied to a series of 113,464 screening mammograms. Screening performance measures were determined for each group. Results demonstrated that compression pressures that are too low lead to a higher recall rate and false positives and compression pressures that are too high reduce detectability of breast cancer. Cancer detection rate and the positive predictive value were optimal in the middle compression category. Currently the only way to achieve pressure guidance in a consequent way during mammographic positioning is by using the Sensitive Sigma Paddle.

“According to European guidelines, breast compression during mammography should be firm but tolerable. However, the lack of consistent compression guidelines has led to wide variation in execution. There is a growing body of research that suggests that compression pressure is a better measurement to standardize mammography leading to a better patient experience and consistent images for better patient care,” added Aarninkhof.

About Sigmascreening
Established as a spin-off company from the Academic Medical Center Amsterdam (AMC Amsterdam), Sigmascreening is an Amsterdam-based 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 first CE-certified product, based on our patented technology. It optimizes compression for every single breast and takes breast sizes and stiffness into account, preventing unnecessary discomfort or pain, resulting in a highly reproducible procedure with a same physical experience and improved mammographic performance, year after year. We aim to introduce new products that will improve mammography and contribute to the early detection of cancer which ultimately can save lives.

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Chris K. Joseph

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