MarginProbe System (Dune Medical Devices) for intraoperative assessment of surgical margins in patients with breast cancer

HAYES, Inc.
Record ID 32016000959
English
Authors' recommendations: Description of Technology: MarginProbe uses principles of radiofrequency (RF) spectroscopy to determine whether breast-conserving surgery margins are clear or not based on specific differences in dielectric properties of malignant and benign cells. The MarginProbe System includes a freestanding portable console unit with a user interface and a disposable, sterile probe. In using MarginProbe, a surgeon takes 5 to 12 measurements on each of 6 margin surfaces of a lumpectomy specimen by touching the disposable probe to the specimen surface. Via the probe, the device delivers a wide range of RF signals to excised tissue and analyzes levels of reflection and absorption of RF energy within the specimen. Each measurement takes approximately 1 second. A classification algorithm compares the specimen with known tissues in a database of cancerous and noncancerous breast tissues, generating visible and audible output that categorizes the specimen surface as positive or negative for the presence of cancer cells. Patient Population: MarginProbe is indicated for intraoperative use, in conjunction with standard of care methods (such as intraoperative imaging and palpation), to assess excised tumor margins for the presence of malignant cells in patients who undergo lumpectomy for previously diagnosed breast cancer.
Details
Project Status: Completed
Year Published: 2016
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: United States
MeSH Terms
  • Humans
  • Breast Neoplasms
  • Mastectomy, Segmental
Contact
Organisation Name: HAYES, Inc.
Contact Address: 157 S. Broad Street, Suite 200, Lansdale, PA 19446, USA. Tel: 215 855 0615; Fax: 215 855 5218
Contact Name: saleinfo@hayesinc.com
Contact Email: saleinfo@hayesinc.com
Copyright: 2014 Winifred S. Hayes, Inc
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