December 07, 2009

ALISO VIEJO, Calif. – The SAVI® applicator for breast brachytherapy is a safe, effective therapy for breast cancer, according to a newly published study in a peer-reviewed journal. The study showed that SAVI’s unique design provides fewer complications, excellent cosmetic results, outstanding dosimetry and increases the number of women eligible for breast brachytherapy.

The study was conducted by researchers at the Moores UCSD Cancer Center and published in the October-December 2009 issue of the prestigious Brachytherapy journal.

Researchers found that radiation exposure for healthy tissue was “exceedingly low” because of the multi-catheter design of SAVI. No serious complications were reported, including no symptomatic persistent seromas, no persistent edema or breast pain. There was one case of asymptomatic fat necrosis reported at the 18-month follow-up mammogram. There were no local recurrences of cancer.

The study was a retrospective review of the first 30 patients to receive treatment with SAVI at the Moores UCSD Cancer Center. The median follow-up for the subjects was 12 months.

“Great progress has been made in breast brachytherapy technology,” said lead author Catheryn Yashar, M.D. “With SAVI, we seem to have a device that overcomes some of the most significant drawbacks of other methods. The device’s versatility means that many more women can take advantage of the convenience of breast brachytherapy, and be confident in its safety and results.”

Yashar is associate professor of radiation oncology at the UC San Diego School of Medicine and chief of breast and gynecological radiation services at the Moores UCSD Cancer Center.

Many breast cancer patients with small breasts or skin spacing issues (those whose tumor is close to the skin surface) cannot be treated by other forms of breast brachytherapy. For example, some balloon brachytherapy applicators cannot be used on smaller cavities or those close to the skin surface or other body structures.

Ten (33%) of the patients in the UCSD study would not have been eligible for balloon brachytherapy treatment because of skin spacing issues. The design of SAVI allowed all of them to receive breast brachytherapy with the device.

SAVI is implemented as part of breast conservation therapy, encompassing lumpectomy surgery to remove the breast cancer and follow-up radiation. In this case, the radiation is delivered inside the breast by brachytherapy.

The device’s multi-catheter design enables physicians to carefully direct and modulate the radiation dose. By using a more precisely targeted dose of radiation, SAVI treats the tissue surrounding the lumpectomy cavity while minimizing the exposure of healthy tissue to radiation. SAVI treatment is completed in just five days compared to the six weeks of treatment, five days a week, that are typically required by traditional, external-beam radiation treatment.

The SAVI applicator is made by Cianna Medical, Inc.

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 SAVI.us.