MHLW Approval Granted For Savi Breast Brachytherapy
Cianna Medical has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to market its Savi applicator in the country. Savi delivers accelerated partial breast irradiation (APBI), a five-day course of targeted radiation for early-stage breast cancer patients. The company has partnered with MC Medical, a subsidiary of Mitsubishi, to bring Savi to the Japanese healthcare market. Savi is the first commercially available intracavitary APBI catheter in Japan.
The Savi breast brachytherapy applicator for the delivery of radiation after lumpectomy surgery allows precise sculpting of the radiation dose, and is designed to make the benefits of accelerated partial breast irradiation available to a greater number of women. The strut-based design of Savi allows physicians to deliver customised radiation based on patient-specific anatomy. The product has been in clinical use in the US since 2006; the applicator received CE mark approval in 2009 and has been in clinical use in Turkey and Poland since 2011.