December 14, 2009
ALISO VIEJO, Calif. – Cianna Medical announced it has received ISO 13485:2003 certification for its quality management system for the design, development and manufacture of the SAVI® breast brachytherapy applicator, which delivers targeted radiation therapy for the treatment of early-stage breast cancer.
The certification allows Cianna Medical to continue with the CE Mark registration process, which is required for sales within the European Economic Community. The CE Mark will apply to all four sizes of SAVI and the SAVI Prep® Catheter.
The device’s multi-catheter design enables physicians to direct radiation where it is needed most, while minimizing exposure to healthy structures, like the skin, chest wall or lungs. SAVI’s unique ability to customize radiation based on patient-specific anatomy helps reduce complications typically associated with radiation therapy and allows physicians to offer the five-day treatment to more women.
“This certification is necessary as we expand the distribution of SAVI to international markets,” said Jill Anderson, CEO of Cianna Medical. “Receiving this certification is an important milestone that moves us one step closer towards fulfilling Cianna Medical’s mission, which is to provide more treatment options for women with early-stage breast cancer.”
The SAVI applicator received its 510(K) clearance from the U.S. Food & Drug Administration in July 2006.
About Cianna Medical, Inc.
Cianna Medical, Inc. is a medical device company focused on women’s health and dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI breast brachytherapy applicator, for the delivery of radiation after lumpectomy surgery. The SAVI applicator allows precise contouring of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women. For more information, call (toll-free) 866-920-9444 or visit www.SAVI.us.