The EU's medical directive approval of Dune Medical Devices' product allows marketing of portable, compact system to begin.
Officials from Dune Medical Devices announce that the company has received CE approval for compliance with the European Union's medical directive for its next generation MarginProbe System console. The MarginProbe System Type 1.2 is a more compact and portable version of the MarginProbe System console which will allow users greater flexibility while locating the hardware component of the MarginProbe System in their operating theaters. In addition to its improved aesthetics and compact size, the improvements in overall design allow for streamlined manufacturing and overall lower manufacturing costs.
"We're excited to have achieved another significant milestone as we bring the benefits of the MarginProbe System to more and more patients throughout Europe. This new and improved version of the MarginProbe System allows easier transport for our customers and for our sales representatives and we believe will help to expand the use of MarginProbe in more and more breast surgery cases in the EU," states Dan Levangie, CEO of Dune Medical Devices.
About Early-Stage Breast Cancer Treatment
Breast cancer is the most common type of cancer affecting women in the U.S., with over 285,000 women diagnosed each year.i Increased breast screening awareness and advancements in imaging technology such as mammograms now catch more breast cancer cases in earlier stages, when they are most treatable. In fact, over half of all breast cancer diagnoses are for early-stage cancers. Many of these cases are non-palpable, meaning a tumor cannot be felt during a breast exam.
It is estimated that 60% to 75% of breast cancer cases will undergo a lumpectomy procedure as their initial treatmentv versus mastectomy, which involves the removal of the whole breast. Lumpectomy in combination with radiation therapy is as effective in combating breast cancer as mastectomy, as long as no cancer cells are present on the rim or edge of the removed tissue, also known as "clean margins." Research shows there is no significant difference in overall survival between the two procedures;ii,iii however, if there is cancer at the edge, or a "positive margin," the risk of recurrence increases significantly.
Following a lumpectomy, surgeons will send the removed tissue to the pathology lab where it is analyzed for cancer on the margin. This is critical information because if there is cancer present on the edges of the removed tissue, there is a possibility that cancer still remains in the breast. Once a tissue sample is sent to pathology for analysis, it can take approximately one week or more to receive the lab results that determine if the patient must undergo a repeat surgery.
Inability to know if all cancerous cells have been removed from the breast during the initial lumpectomy procedure results in repeat surgery rates ranging from 30% to 60%.iv
i Journal of the American Medical Association: http://jama.jamanetwork.com/article.aspx?articleid=1104931#Abstract
ii American Cancer Society: http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/acspc-030975.pdf
iii Fisher B, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233-1241.
iv Fisher B, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233-1241.