SenoRx today announced that it has received the right to apply the CE Mark to its Contura(tm) MLB short-term breast radiation balloon catheter. The multi-lumen radiation balloon delivers radiation to the tissue surrounding a lumpectomy cavity following surgery for breast cancer. The CE Mark applies to both the original size Contura MLB, which is designed for lumpectomy cavities of 4 to 5 centimeters in diameter, as well as the more recently cleared, larger-size Contura Shape Select(r) MLB designed for cavities ranging from 4.5 to 6 centimeters. The CE Mark is required for sales in countries within the European Economic Community. SenoRx had previously announced the receipt of 510(k) clearance in the United States for the original Contura in May 2007 and for the larger-size Contura in July 2008.
“We believe having the ability to apply the CE Mark to Contura further strengthens our long-term international growth opportunities,” said Lloyd Malchow, SenoRx President and Chief Executive Officer. “SenoRx is already marketing its EnCor(r) Breast Biopsy system and GelMark(tm) line of tissue markers through local in-country distributors with breast imaging and/or radiology franchises in more than 30 select markets outside the United States. While Contura is currently only being sold in the U.S., we can now begin implementing commercialization plans for the product internationally. We expect to launch Contura in several countries outside the U.S. in 2009 and further expand internationally in a step-wise manner.”