FDA approved device enables surgeons to preserve more breast tissue while reducing the need for additional surgery according to medical study
Paoli, PA, May 10, 2016– According to a new research study from Mercy Medical Center in Cedar Rapids, IA, and the University of Iowa Hospitals and Clinics the use of Dune Medical Device’s MarginProbe®, a tool for assessing clear margins during lumpectomies, led to a 75% reduction in the number of second surgeries needed by breast cancer patients.
The study, which was led by Drs. Vincent Reid, MD, FACS and Jeffrey Coble, MD, also found that the use of MarginProbe enabled their medical team to change from full cavity shavings to directed shavings guided by the device to reduce the overall volume of tissue removed during surgery.
The research study, titled “Margins in Lumpectomy: Transition from a full cavity shave approach to a targeted shaving approach using MarginProbe,” was a poster presentation at the recent American Society of Breast Cancer Surgeons Annual Meeting followed by a podium presentation during the Society of Black Academic Surgeons Annual Meeting. Reid and Cobles work is a retrospective review of surgeries performed on 54 patients between December 2013 and August 2014. The women, who ranged in age from 38 and 84 years old, were compared to a similar patient set who underwent lumpectomies prior to use of MarginProbe.
Details from the study include:
Device Effectiveness: In 11% of the cases, the lumpectomy specimen had positive margins prior to intraoperative assessment. MarginProbe identified all the positive margins in 83% of those cases.
- Positive margins on main specimen = 11% (6/54)
- Identification by the device = 83% (5/6)
- Cancer found in the shavings, even though the main specimen was clear = 5.5% (3/54)
- Clinical benefit provided by the device = 14.8% (8/54)
Re-Excision Rates: The re-excision rate was only 3.7% in cases where the device was used compared to a 15.1% re-excision rate where there was no MarginProbe assessment. This constitutes a statistically significant relative reduction of 75%.
Tissue Volume of Shavings: The study also found that there was a 40% reduction in the amount of breast tissue removed by shavings.
- Volume of tissue removed by shavings in the device set vs. tissue volume of shavings with full cavity shaving = -20 cc
- Volume of shavings removed (relative to main specimen volume), in comparison to full cavity approach = -40%
Traditionally, one-in-four women who undergo a lumpectomy require additional surgery to remove cancer missed during the initial procedure. The Reid study is the latest research to show how MarginProbe, the first and only FDA-approved technology, offers surgeons a real-time detection of cancer at the surface of excised tissue specimens during surgery. Dune Medical recently announced the findings of a study conducted by Dr. James Pellicane and his team at Bon Secours Virginia Breast Center, which demonstrated an overall 79% reduction in re-excisions when the MarginProbe device was used.“Not only has implementing the use of MarginProbe with every lumpectomy patient reduced the volume of tissue I take from my patients, but it’s also significantly reduced my re-excision rate.” Said Reid. “Targeted shavings with MarginProbe have given me a significant clinical improvement in cosmetic outcomes and satisfaction for my patients.”
“We are pleased to see how the increasing body of MarginProbe research demonstrates consistently that the re-excision rates are reduced by greater than 50% giving patients and surgeons greater confidence to answer the question ‘did we get it all?’” Said Lori Chmura, President of Dune Medical Devices, Inc. “What is interesting about this study is that it went further than just showing reduction in re- excision rate. It shows that changing the standard of care from full cavity shavings to targeted shavings with MarginProbe significantly reduces both the re-excision rate and the tissue volume removed, creating the best possible patient outcome.”
About Dune Medical Devices
Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony, CEO, to realize the extraordinary medical potential of its proprietary tissue characterization technology. Offering surgeons and radiologists the real-time ability to identify cancerous tissues and react immediately, this technology holds the potential for a broad range of surgical and diagnostic applications. Dune Medical Devices is a privately held company with offices in the U.S. and Israel. For more information, please visit www.dunemedical.com.
Disclaimer: The views and opinions expressed in this article are those of the authors and do not necessarily reflect the official policy or position of Dune Medical.