A study recently presented during the 2017 American Society of Breast Surgeons annual meeting demonstrates that proper use of Dune Medical Devices’ intraoperative margin assessment device, MarginProbe, results in a significant difference in the total re-excision rate during breast conserving surgery- the standard option for patients with early stage breast cancer. Re-excision rates vary substantially, however, the recently reported average across multiple institutions was 25%.
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. John Providence in Detroit, MI, reports an analysis of MarginProbe’s effectiveness by comparing 120 consecutive cases prior to use of the probe and 120 consecutive cases after institution of its use. Reliability of the device was determined by comparing postoperative pathology reports. This study “Impact of utilizing a real-time, intraoperative radiofrequency probe for margin assessment in breast conserving surgery” shows that there was a significant difference in the total re-excision rate when using the MarginProbe- 61% lower than the historical comparison group. The historical re-excision rate was 18% and reduced to 7% with the routine use of MarginProbe. The study also showed that there was no difference in tissue volume removed between the control group and the device group.
“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 and the associated improvements in patient’s’ quality of life is exactly the kind of value-based proposition that new medical devices need to offer the healthcare continuum.”
“Thanks to the work of Dr. Kupstas with her mentors Dr. Falk and Dr. Wesen, we now have compelling evidence that continues to support our assertion that routine use of MarginProbe in lumpectomy procedures for breast cancer generates lower re-excision rates, lower overall healthcare costs and improvements in patient outcomes,” said Lori Chmura, Chief Executive Officer at Dune Medical Devices. “Working to improve the standard of care around cancer surgery is what we strive for every single day.”
The MarginProbe System
The MarginProbe System consists of three primary components — the Sensor, the Attachment Mechanism and the Algorithm — designed to provide reliable performance and ease of use for surgeons within the operating room environment. The system utilizes RF Spectroscopy to analyze tissue to identify both normal and malignant cells.
The Science – RF Spectroscopy for Margin Assessment
Cancerous cells and healthy cells have very different electromagnetic properties. The bioelectric differences between them can be detected using RF spectroscopy.
Once detected, the electromagnetic “signature” of cancerous cells can be compared to thousands of other cell signatures using Dune’s proprietary algorithm. A binary result is then reported to the surgeon in real time to support a decision regarding the removal of additional tissue from the breast.
About Dune Medical Devices
Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony to realize the extraordinary medical potential of its proprietary tissue characterization technology. With initial indications in breast, this technology holds the promise 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.