One of 8 women will develop breast cancer over the course of her lifetime1, accounting for 1.4 million new cancer cases annually (23% of all cancer cases in women)2. Surgery to remove the cancerous tissue is the first line of treatment for breast cancer. Lumpectomy, also termed Breast Conserving Surgery (BCS) is the preferred surgical treatment, and more than 700,000 lumpectomy procedures are performed annually worldwide.
Unlike mastectomy, in which the entire breast and lymph nodes are removed, lumpectomy involves only removal of the cancerous tissue and a margin of healthy tissue. Achieving an adequate surgical margin (‘clear margin’) to reduce recurrence rates and improve patient outcomes has been well established.
Clear or negative margins refer to having a cancer-free margin surrounding the cancerous tissue.
If cancerous tissue is present at the margin of the excised lump (positive margin) re-excision surgery may be required, leading to additional patient anxiety and expenses, diminished cosmetic results and delays in adjuvant therapy. In the vast majority of medical centers, margin assessment is still done solely by the pathologist following surgery, so that the result is obtained only few days later.
This leads to high re-excision rates – public clinical literature illustrates that one in 3 women have to return for a second surgery3,4. A real-time margin assessment tool is needed for minimizing re-excision rate. An accurate margin assessment in the operating room is expected to further improve patient outcomes by optimizing intraoperative radiation therapy as well as reconstructive surgery.
Improved patient care, by achieveing clear margins in a single surgical procedure
Investigational device. Limited by Federal (or United States) law to investigational use