News | October 09, 2013

Cianna Medical Receives Approval in Japan for SAVI Breast Brachytherapy

SAVI is the first commercially available intracavitary APBI catheter in Japan

October 9, 2013 — Cianna Medical Inc. announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its strut adjusted volume implant (SAVI) applicator in Japan. 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 Inc., a subsidiary of Mitsubishi Corporation, to bring SAVI to the Japanese healthcare market.

"Entry into Japan is core to our initiative to make SAVI available wherever there is an emergent call to action regarding the treatment of early-stage breast cancer," said Jill Anderson, president and CEO, Cianna Medical. "SAVI uniquely allows women with early-stage breast cancer to be treated in a shorter time frame with less complications, empowering them to reclaim control of their lives more quickly. MC Medical is the ideal partner to convey SAVI's benefits to the Japanese medical community."

According to research, breast cancer rates in Japan will rise by an estimated 24 percent by 2019 to reach 57,000 women compared to 46,000 cases in 2010.  SAVI's strut-based design allows physicians to deliver customized radiation based on patient-specific anatomy. In Japan, where women have relatively smaller breasts, SAVI could make APBI available to a broader swath of patients.

SAVI has been in clinical use in the United States since 2006. The applicator received its CE marking in 2009 and has been in clinical use in Turkey and Poland since 2011. More than 14,000 women have been treated with SAVI.

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