Probe That Checks For Cancer On The Margin During Breast Lumpectomy Gets FDA Approval
Lumpectomy (surgery to remove a lump of tissue), in combination with radiation therapy, is as effective in treating breast cancer as mastectomy: but only if no cancer cells are present on the edge or rim of the removed tissue, also known as "clean margins".
In a statement announcing the approval via PR Newswire on Wednesday, Dune Medical Devices says its MarginProbe System, which has been available in Europe since 2008, significantly improves a surgeon's ability to find cancer on the tissue margin during the lumpectomy, and also significantly reduces "pathologically positive margins" following initial lumpectomy surgery.
The device comprises a single-use probe and is designed to analyze tissue within 20 minutes of excision. It takes only a few minutes to compare the "electromagnetic signatures" of the margins of the excised tissue to a bank of stored signatures from healthy and cancerous tissue, and give an assessment of whether the removed tissue is cancerous or not.
Often, early stage breast cancer is detected via mammography, which can "make the process of achieving negative margins more challenging," says Susan K. Boolbol, who is Chief of Breast Surgery at Beth Israel Medical Center, and who worked on the pivotal clinical trial that the FDA reviewed.
Following a lumpectomy, surgeons normally send the removed tissue to a pathology lab to see if there are any cancerous cells on the margins. It can take a week or more for the results to come back. This can be an anxious time for patients waiting to find out if they need another operation.
The results of the trial, which involved 664 patients recruited from several centers, showed MarginProbe was over three times more effective in finding cancer on the margin during lumpectomy than traditional methods.
Having the probe means surgeons can significantly reduce the number of patients with positive margins following initial surgery, says the company.
Boolbol says before the probe, their "ability to assess the microscopic margin status in the operating room has been limited".
"Following their breast cancer surgery, telling a patient that they need more surgery can be an emotional issue for doctors and patients. This may result in tremendous anxiety and frustration," she says.
Susan Scanlan, a breast cancer survivor and Chair of the National Council of Women's Organizations in the US, agrees:
"When I was first diagnosed with breast cancer I decided to undergo a lumpectomy, but like many others, I was told I had cancer on the margin following the procedure. The mental distress of having to go back for a repeat surgery undermined my confidence."
"I believe MarginProbe offers women the additional peace of mind that they can move on to the next step in fighting the disease and put breast cancer in their rearview mirror," says Scanlan.
Written by Catharine Paddock PhD