August 1, 2018 (Alpharetta, Ga.) – A study recently published in the American Journal of Surgery demonstrates that proper use of Dune Medical Devices’ intraoperative margin assessment device, MarginProbe, results in a significant identification of positive margins and a resulting reduction in the re-excision rate for breast conserving surgery – the standard option for patients with early-stage breast cancer.
The research led by Amanda Kupstas, MD, Warda Ibrar, MD, D. Richard Hayward, PhD, Daniel Ockner, MD, Cheryl Wesen, MD, FACS, and Jeffrey Falk, MD, FACS, of St. Johns Providence in Detroit, MI, reports an analysis of MarginProbe’s effectiveness by comparing 120 consecutive breast conserving surgery cases prior to use of the probe and 120 consecutive cases after implementation of its use. Reliability of the device was determined by confirming findings with post-operative pathology reports. This study, “Impact of utilizing a real-time, intraoperative radiofrequency probe for margin assessment in breast conserving surgery,” reported a 61% reduction in the relative re-excision rate when using the MarginProbe compared to the historical comparison group. The historical absolute re-excision rate was 18% and reduced to 7%. The study also showed that there was no difference in tissue volume removed between the control group and the device group, demonstrating that a significant reduction in re-excision can be achieved without a negative impact on cosmetic outcome. These findings support the ongoing effort to improve patient outcomes and reduce costs and variability in re-excision rates among surgeons, institutions and geographies.
“Any device that yields significantly lower re-excision rates is a tool that hospitals and breast surgeons should seriously consider using,” said Falk. “MarginProbe’s capacity to reduce instances of costly second surgeries while improving quality of life is exactly the kind of value-based proposition that new medical devices need to offer in today’s healthcare environment.”
“Thanks to the work of Dr. Kupstas with her mentors Dr. Falk and Dr. Wesen, we have further compelling evidence that supports a body of clinical data demonstrating that routine use of MarginProbe in lumpectomy procedures for breast cancer generates lower re-excision rates, which should lower overall healthcare costs and improve patient outcomes,” said Lori Chmura, Chief Executive Officer at Dune Medical Devices. “These results are particularly important as it is well known that positive margins are a risk factor for delaying the initiation of adjuvant therapy; and delays in adjuvant therapy have been reported to have negative effects on survival rates for women undergoing breast cancer surgery1. Furthermore, re-excision is significantly associated with a decrease in breast satisfaction among women receiving breast conserving therapy2. Giving women the confidence that all of their cancer has been removed and allowing them to return to their lives before their cancer diagnosis is our mission.”
About Dune Medical Devices
Imagine not having to wonder, did we get it all?
At Dune Medical Devices, we believe in reducing the anxiety that waiting for pathology results places on a patient and their families. Our solutions, which are developed on a first-of-its kind RF Spectroscopy platform, can differentiate cancerous from healthy tissue based on electromagnetic properties of tissue, making it increasingly possible for patients and physicians to answer the question, “did we get it all?”
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- Riba, L.A., Gruner, R.A., Fleishman, A. et al. Ann Surg Oncol (2018). https://doi.org/10.1245/s10434-018-6351-7
- 2. Fuzesi S, et al. Satisfaction with Breast Conserving therapy after re-excision: A study using the BREAST-Q, A patient reported outcomes measure in breast surgery. SSO 2018.