September 23, 2008
Largest SAVI Study Calls Experience ‘Outstanding’
Clinical experience with the SAVI(TM) breast brachytherapy applicator has been outstanding, according to a scientific poster presented at the 2008 Breast Cancer Symposium, Sept. 5-7, 2008 in Washington, D.C. The retrospective study evaluated the first 102 patients to undergo therapy with the device, making it the largest clinical review of the SAVI applicator to date.
Researchers concluded that SAVI expands the number of women with early-stage breast cancer who are eligible for breast brachytherapy. More than half of the evaluated patients were not candidates for balloon brachytherapy, due to skin spacing or breast size. Median follow-up time in the study was a full 10 months. The study was co-authored by physicians from the Department of Radiation Oncology, University of California San Diego, and Arizona Oncology Services (AOS) and the Breast Care Center of the Southwest, both in Phoenix, Ariz.
"The flexibility of SAVI expands the number of women for whom accelerated partial breast irradiation is a viable treatment option," said Victor Zannis, M.D., a surgeon at the Breast Care Center of the Southwest and a co-author of the study. "The device is notable for its ability to conform to specific patient anatomy, as well as its ability to be used in small breasts and in proximity of normal body structures such as the skin or chest wall."
SAVI is a single-entry, interstitial-style device that delivers radiation as part of breast conservation therapy. By more precisely targeting radiation therapy, the device treats the tissue where the cancer is most likely to recur, while minimizing the exposure of healthy tissue such as the skin, heart, lungs and ribs.
"Cianna Medical is proud to play a leading role in advancing breast cancer treatment, by providing more women with the option of customized care," said Jill Anderson, the company's President and CEO. "Thanks to the sophistication of this technology, the SAVI applicator makes a simple five-day course of radiation available to twice as many women than are currently eligible for balloon brachytherapy."
According to researchers, what differentiates SAVI from other applicators is that it combines the ease of placement of single-entry brachytherapy devices with the improved dose modulation of interstitial brachytherapy.
"SAVI's real advance is the nature of its open architecture design with multiple catheters. This makes it possible to contour the dose and gives physicians the ability to cover the target area while minimizing radiation exposure of non-targeted tissue," said Catheryn Yashar, M.D., assistant professor and chief of breast and gynecological services in the UC San Diego Department of Radiation Oncology and a lead author of the study.
Unlike balloon brachytherapy applicators, which require skin margins of several millimeters, SAVI has no such skin spacing limitations. In the study, 23 patients had a skin spacing of less than or equal to 7 mm, and 34 patients had a chest wall spacing of less than or equal to 7 mm, yet the dose to normal structures remained "exceedingly low."
Patient tolerance of the procedure was excellent. Of the 102 patients evaluated, only 8% had a palpable seroma, all of which were asymptomatic. In contrast, seroma rates with balloon brachytherapy are reported to vary from 15%-60%. The infection rate with SAVI in the study was 3%, which is comparable to the average rate of infections for breast procedures and substantially less than published infection rates for balloon brachytherapy.
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 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 about the company, call (toll-free) 866-920-9444 or visit www.SAVI.us.