The FDA has approved a healthcare industry first: a system that allows for breast biopsies to be performed in the same room with the same equipment as a mammogram.
Called the Pristina Serena Bright, the system uses contrast-enhanced mammography to pinpoint any suspicious areas. Then, if a patient has a lesion that looks problematic enough to be biopsied, that procedure can be performed immediately in the same room with the same equipment and the same staff.
The entire system reduces how much time a patient spends undergoing testing, how much time they spend waiting, and offers less overall discomfort.
Here’s how it works.
The Serena Pristina is the brainchild of GE Healthcare and combines different technologies they’ve created. The mammogram component uses SenoBright CESM (contrast-enhanced spectral mammography), which is similar to an MRI but more accurate. (The company calls it a “next level mammogram.”)
This type of mammogram is especially helpful for women with dense breasts. Dense breast tissue can often show up as white on traditional mammograms and make it difficult to discern any cancerous areas. In CESM, an iodinated contrast agent in injected into the patient (similar to what is done in an MRI), and cancerous tissue absorbs the liquid and is highlighted in the films that are taken. This makes any problematic areas much clearer.
The healthcare team can access the breast from different angles, including the side, which reduces the need for repositioning and adjusting the breast tissue (and results in less discomfort for the patient).
The breast exam using CESM is usually completed in less than seven minutes. The images are immediately available to a radiologist, who can then review the films and assess if any areas need a biopsy.
If needed, a breast biopsy can be done in less than 15 minutes. The system has a laser guide that precisely targets where the anesthesia and biopsy needle need to go. There is no guesswork, and no waiting.
“The waiting list for MRI-guided biopsy can be as long as several weeks,” said Dr. Rodrigo Alcantara, Head of Breast Imaging Section at Hospital del Mar in Spain. “This new mammography-guided biopsy techniques allows for a comfortable experience and provides women with answers quickly.”
Reducing time spent undergoing procedures and awaiting results can not only allow for a quicker diagnosis and treatment plan, but it also greatly reduces a patient’s anxiety.
“Now more than ever, it is critical we put the comfort of patients first and get them answers as fast as possible. We are proud to announce this FDA clearance during a time our customers need this type of innovation the most,” said President and CEO of Women’s Health at GE Healthcare, Agnes Berzsenyi. “We look forward to bringing this technology to the market in the upcoming months and hope it can help improve breast cancer outcomes for women during this time of uncertainty.”
Learn more about the Pristina Serena in this video.