- A medical device that allows surgeons to check for cancer cells around the edges of a breast tumor and remove them immediately could reduce the need for repeat procedures and make breast cancer surgery more efficient, The Wall Street Journal reports.
- The hand-held MarginProbe system — made by Paoli, PA-based Dune Medical Devices — uses RF spectroscopy to analyze tissue and distinguish normal cells from those that are malignant. A flashing blue light indicates an area is free of cancer cells.
- More than 10,000 patients have had lumpectomies using MarginProbe, according to Dune Medical’s recent Q4 2016 report. But price remains a barrier to broader adoption as a new device is required for each procedure — at $1,000 a pop.
More women choose lumpectomy than mastectomy (64.5% versus 35.5%, respectively) for early-stage breast cancer, according to BreastCancer.org, but that number is dropping. One of the drawbacks to lumpectomy has been the worry that stray cancer cells could be left behind, requiring follow-up procedures and risking that the disease could advance.
Research shows that about 21.6% of women undergoing lumpectomy for breast cancer undergo one or more re-excisions. However, a study published in August 2016 in the Archives of Gynecology and Obstetrics found that using MarginProbe in the initial procedure lowered the chances of a re-excision by 51%. A separate study published last December found 57% fewer re-excisions in procedures involving MarginProbe, according to the WSJ.
The FDA approved MarginProbe in December 2012, and it has been in use since 2013. Last year, the company won approval for modifications that brought the device into compliance with changes in the EU’s Restriction of Hazardous Substances (RoHs) legislation.