DOTmed News: Can you describe how the study was conducted?

SMF: The way the study was done, we would do our normal lumpectomy, if patient was in trial during the surgery, the envelope would be opened and if it said “device” we would use MarginProbe and “control” would mean no margin probe. So that’s how it was done and it showed benefits to the probe, and that led to FDA approval of the device.


In the trial we had restrictions, we could only use it on the lumpectomy surface, but we would like to use it in the cavity, the space behind where the lump was removed from. Now, with FDA approval — although it isn’t specifically approved for that indication — I can use the device both for lumpectomy and for the additional margins of the cavity and we’re in the process of designing clinical trials using it that way.

So we’re coming out of a long hiatus from 2009 until just a few months ago of not using the probe and now we have the probe and we’re using it on a regular basis and I think since then we’ve used it on maybe a dozen patients. The experience has been very good.

DOTmed News: Has it saved money for your practice?

SMF: I think of the dozen there have been two or three patients where management was changed based upon it. And that’s what we expect. My personal re-excision rate in this five year interval has been something like 10 to 15 percent, which is pretty good when you look at the literature overall.

Re-incision rates are very difficult to use as a quality metric because if a surgeon is very prone to doing mastectomy — as opposed to lumpectomy — and only does lumpectomy for the smallest tumors, the best characterized by mammography or ultrasound, that surgeon is going to have a very low re-incision rate because they aren’t doing it on patients who may have margin issues.

The vast majority of my patients receive lumpectomy, so having that rate is pretty good but if MarginProbe gets me down to 3 or 5 percent then that’s a home run. And it’s not just the finances of the re-excision, when you do a second surgery shortly after a first surgery there is still healing going on, scar tissue, a lot of changes to the tissue. The cosmetics are always worse after a second incision. And for the patient, from a psychological emotional point of view, it’s not great.

DOTmed News: What is the ultimate goal with the MarginProbe?

SMF: We want to get to a metric where we do the smallest lumpectomy possible yet have clean margins. We think the MarginProbe will help us with that. It may help reduce re-incision rates—and its hard to get to zero ever, but we want to get as close to zero as possible, and also be able to do it by removing just enough tissue to have clean margins.

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