September 3, 2009 - Hologic Inc. today announced the U.S. Food and Drug Administration (FDA) granted 510(k) for the MammoSite ML radiation therapy system.
With its multi-lumen design, this new device gives radiation oncologists the ability to shape the radiation dose for typical cases and treat patients who are otherwise not appropriate candidates for traditional brachytherapy.
Hologic's MammoSite therapy system, first cleared by the FDA in 2002 as a single-lumen device, is the most widely used form of accelerated partial breast irradiation (APBI) in the United States. It has been used to treat more than 50,000 breast cancer patients in the U.S.
By employing the MammoSite system, the physician can deliver targeted radiation therapy directly to the area where cancer is most likely to recur,(i) allowing a full course of radiation to be delivered in just five days. Additionally, targeted therapy of the breast limits radiation exposure to normal, healthy tissue. This targeting helps minimize side effects such as skin discoloration and scarring, burning, fatigue, and damage to surrounding organs.
In 2008, approximately 240,000 cases of breast cancer were confirmed in the U.S. Fortunately, today more than half of breast cancers are diagnosed when the disease is still in its localized stage.(ii) Early detection allows breast cancer patients to choose breast conservation therapy, which preserves the breast by relying on tumor excision via lumpectomy, followed by radiation therapy, to reduce the likelihood of recurrence. According to the National Institutes of Health, breast-conserving surgery plus radiation therapy is preferable to total mastectomy because it provides survival equivalence while preserving the breast.(iii)
The MammoSite systems are comprised of an inflatable balloon catheter in which a radioactive source is introduced for therapy delivery. The inflatable balloon is inserted into the surgical cavity remaining after removal of the tumor. This local placement of the balloon provides for therapeutic delivery of a five-day course of radiation to the tissue most likely to contain residual cancerous cells following surgery, while reducing radiation exposure to adjacent healthy tissue. Using the MammoSite multi-lumen catheter, the radiation oncologist has the ability to shift the radiation dose to the areas that need it most and shift the dose away from areas that do not require it.
The Company expects to commercially launch MammoSite ML during the first quarter of fiscal year 2010 (quarter ending December 26, 2009).
References
(i) King TA, Bolton, JS, Kuske RR et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T(is,1,2) breast cancer. Am J Surg. 2000; 180:299-304.
(ii) American Cancer Society, Breast Cancer Facts and Figures: 2007-2008.
(iii) Consensus statement on treatment of early-stage breast cancer. National Institutes of Health, 1992.
For more information: www.Hologic.com
May 03, 2025 
