FDA Clears Bayer for Expanded Use of MEDRAD® Stellant FLEX CT Injection System in Contrast Enhanced Mammography

Bayer announced today the company received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the indication of its MEDRAD^® Stellant FLEX Computed Tomography (CT) Injection System with Certegra® Workstation for use in Contrast Enhanced Mammography (CEM). Through the use of iodine-based x-ray contrast agents, CEM can allow for better visualization of abnormalities in breast tissue that may not be visible with standard mammography.

“This FDA clearance underscores Bayer’s continued commitment to women’s health, and we are pleased to now support CEM as another alternative screening option for women,” said Dennis Durmis, Head of Region Americas, Bayer Radiology.

CEM uses an iodinated intravenous contrast agent in combination with mammography, allowing the x-ray image to become enhanced to potentially detect hidden lesions or masses in the breast. Stellant FLEX offers enhanced benefits over manually administered injections by enabling accurate contrast dose administration. Additionally, Stellant FLEX provides consistent enhancement of tumor tissue that may be missed with a standard mammogram. In women with dense breast tissue, CEM has been shown as superior to both standard mammography and breast ultrasound in detecting breast cancer.[i]

In recent years, 510(k) market clearance has been granted for CEM equipment using existing iodine-based x-ray contrast media. This CEM equipment utilizes power injection systems to deliver the same iodine-based contrast agents that are used in CT procedures. Prior to this clearance, Bayer’s MEDRAD Stellant FLEX CT Injection System was indicated for delivery of contrast media and saline, specifically in CT applications. The device operates in the same manner, independent of whether the injector is used in a contrast-enhanced CT application or a contrast-enhanced mammography application.

Introducing a new FDA indicated breast screening method aligns with the increased focus on women with a higher risk for breast cancer. Recently, to help emphasize the importance of the unique screening needs for women at high risk, organizations such as the American Society of Breast Surgeons, American College of Radiology, and the Society for Breast Imaging issued new guidelines, including reevaluating the existing screening guidance to reinforce that women who are at higher risk undergo supplemental screening beyond a mammogram. The clearance is especially significant for the 43-46% of US women older than age 40 with dense breasts who may require additional screening beyond a standard mammogram.[ii]

“Thirty-eight states and the District of Columbia now require some level of mammography density information in the results letter sent to patients. Dense tissue both increases the risk of developing breast cancer and of cancer, if present, to be masked on mammography. In dense breasts supplemental screening methods increase cancer detection over mammography alone, even after a ‘normal’ mammogram.” JoAnn Pushkin, Executive Director, DenseBreast-info, Inc.

Designed to drive efficiencies, the primary features of Stellant FLEX include 150 mL and 200 mL syringe sizes, beacon technology for easy visualization of fluids, syringe size barcode identification, lot and expiry date information, increased accuracy and automation of documentation with contrast barcode reader, and a streamlined training program.

For more information on the MEDRAD Stellant FLEX CT Injection System, please visit www.stellantflex.com.

The announcement expands upon Bayer's existing focus on breast imaging. The Bayer portfolio also includes a contrast agent approved for breast imaging along with MRI (Magnetic Resonance Imaging).

[i] Sorin V, Yagil Y, Yosepovich A, et al. Contrast-Enhanced Spectral Mammography in Women With Intermediate Breast Cancer Risk and Dense Breasts. AJR Am J Roentgenol 2018; 211:W267-W274

[ii] Monticciolo DL, Newell MS, Moy L, Niell B, Monsees B, Sickles EA. Breast Cancer Screening in Women at Higher-Than-Average Risk: Recommendations From the ACR. J Am Coll Radiol. 2018;15:408-414.