MENLO PARK, CalifProDuct Health, Inc. has launched the ProDuct Breast Aspirator and Catheter for use in ductal lavage.
Preliminary data of a trial of ductal lavage in 515 high-risk women showed atypical breast epithelial cells in 15% of women and high-grade atypia in 4%. In two cases of malignant and markedly atypical cells, both women had excisional biopsies confirming ductal carcinoma in situ (DCIS), even though mammograms were normal before and after ductal lavage (36th ASCO, New Orleans, abstract 295).
The breast aspirator applies mild suction to draw fluid from the nipple and is used to identify which milk ducts to lavage. Previous research has shown that nipple aspirate fluid production upon nipple aspiration is associated with roughly a doubling in breast cancer risk, the company said in a news release.
To perform the ductal lavage procedure, a flexible microcatheter is inserted approximately half an inch into the milk ducts through the natural nipple opening. A small amount of saline solution is introduced, washing cells out of the lining of the milk ducts.