FDA Approves Device To Check Margins During Surgery ...

cp418 · January 2013

FDA Approves Device To Check Margins During Surgery For Breast Cancer.

Medscape (1/3, Chustecka) reports that the MarginProbe, "a device for use during breast cancer surgery to check if margins are clear of cancer, has been approved in the United States by the US Food and Drug Administration." Findings "from a pivotal clinical trial in 664 women who underwent a lumpectomy showed that the new device was 3 times more effective in finding cancer in the margins when compared with traditional intraoperative imaging and palpation assessment, according to the manufacturer." The "trial is awaiting publication, but some of the data were presented recently at the 2012 Breast Cancer Symposium and were highlighted in a press briefing organized by the American Society of Clinical Oncology."

cp418 · January 2013

http://bostonglobe.com/business/2013/01/02/dune-medical-wins-fda-approval-sell-new-breast-cancer-tissue-assessment-tool/km72J2iXqbt2Sv3G0mnHRJ/story.html

Tool OK’d to help find all cancerous breast tissue

Dune Medical will build its sales force at a new Boston office

http://www.marketwatch.com/story/dune-medical-devices-receives-fda-approval-for-breakthrough-advancement-in-breast-cancer-surgery-2013-01-02

JohnSmith · March 2016

New study confirms MarginProbe demonstrates a 51% reduction in re-excision procedures
IDC patients saw 89.8 percent reduction in re-excisions in a 322 patient prospective study

PAOLI, Pa., Feb. 29, 2016 /PRNewswire/ -- New research lead by Professor Jens-Uwe Blohmer, director of gynecology and the breast center of the Charité, in Germany, demonstrates that proper use of MarginProbe, the first and only FDA-approved device used to enable real-time detection of cancer at the surface of excised tissue specimens, results in a significant decrease in second surgeries.
Traditionally, one in four women who undergo a lumpectomy procedure require a re-excision to remove cancer missed during the first procedure.
The study found that the number of women who required a re-excision following a lumpectomy was reduced by 51% when MarginProbe was used during the initial procedure.
Dramatic re-excision reduction was also shown for DCIS and ILC patients.
http://www.morningstar.com/news/pr-news-wire/PRNew...

FDA Approves Device To Check Margins During Surgery ...

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