Grand Strand Medical Center October 08, 2014

Myrtle Beach, SC – Grand Strand Medical Center announced today that they are on the leading edge of breast care by now offering the Invenia ABUS (Automated Breast Ultrasound System), approved by the FDA for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue and no prior interventions.

“We are excited to add the Automated Breast Ultrasound system from GE Healthcare to our comprehensive breast cancer screening program. By offering ABUS in addition to mammography for our patients with dense breast tissue, we anticipate improving detection for small cancers that cannot be seen on a mammogram alone in these women. We believe ABUS will become an integral part of our practice for the detection of breast cancer,” said Dr. Michael Brown, Radiologist with Grand Strand Medical Center.

Dense breast tissue not only increases the risk of breast cancer up to 4-6 times but also makes cancer more difficult to detect using mammography, according to multiple large studies. One study, published in the New England Journal of Medicine, showed mammography sensitivity is reduced by 36 to 38 percent in women with dense breasts, as density masks the appearance of tumors (Boyd, et al, NEJM 2007:356:227-36M). As breast density goes up, the accuracy of mammograms goes down (Kolb et al Radiology, October 2002). As a result, several states have passed laws mandating that women be notified if their breasts are dense, and may offer supplemental imaging as appropriate.

“Mammography is an effective tool for the detection of breast cancer; however, it doesn’t work equally well in all women, particularly those with dense breast tissue,” added Dr. Brown.

The Invenia ABUS system is designed to enhance the consistency, reproducibility and sensitivity of whole breast ultrasound, demonstrating a 35.7% improvement in cancer detection (sensitivity) in women with dense breasts without prior breast intervention. (FDA PMA Approval P110006, Sept. 18, 2012.)

The unique challenges of breast cancer screening led to important technology innovations that result high resolution images that can be acquired rapidly. Clinically, this offers an efficient option that provides enhanced resolution and contrast, making the Invenia ABUS system well positioned to address the workflow challenges of breast cancer screening and improve the detection of breast cancer in women with dense breasts.

Dr. Brown recommends that women get regular mammograms as suggested by their doctor. If they have been informed that they have dense breast tissue, they should talk to their doctor about their specific risk and additional screening tests that might be appropriate.

*InveniaTM ABUS Clinically Proven to Increase Cancer Detection by 35.7%; Recently Installed at Grand Strand Medical Center*

Brief Statement

The Invenia ABUS is indicated as an adjunct to mammography or breast cancer screening in asymptomatic women for whom screening mammography findings are normal or benign(BI-RADS® Assessment Category 1 or 2), with dense breast parenchyma (BI-RADS Composition/Density 3 or 4),and have not had previous clinical breast intervention. The device is intended to increase breast cancer detectionin the described patient population. The Invenia ABUS may also be used for diagnostic ultrasound imaging of thebreast in symptomatic women. See the device manual for detailed information, contraindications, warnings,precautions, potential adverse events.