October 09, 2007

SAN FRANCISCO – The SAVI™ applicator used in breast brachytherapy produced promising results in an early clinical trial with patients, according to a study presented at the American Society of Clinical Oncology’s 2007 breast cancer symposium.

An advancement in breast conservation therapy, SAVI is a single-entry, multi-catheter device that delivers radiation treatment inside the breast for patients with early-stage breast cancer. By delivering a more precisely targeted dose of radiation, SAVI treats the tissue surrounding the lumpectomy cavity while minimizing radiation dose to healthy tissue.

In the study, 15 patients were treated with SAVI. The majority of patients qualified for breast brachytherapy because SAVI was an available option. If breast brachytherapy using a balloon had been the only option, sixty percent (60%) of the participants would have been disqualified, due to skin spacing and other anatomical restrictions.

“Our study provided evidence that it is possible to safely treat women with SAVI who otherwise would not be able to receive breast brachytherapy,” said Dr. Robert Kuske, one of the study authors. “The device’s multi-catheter design makes it possible to contour the dose and therefore minimize risk to non-targeted tissue and body structures.”

Device geometry and conformity did not change during the entire course of treatment, as confirmed by serial CT scans. Cosmesis was reported as good or excellent (using the Harvard criteria) in all cases within a follow-up range of 3 months to 10 months.

None of the patients experienced complications related to persistent seroma at follow-up intervals of 2 months to 6 months.

In addition to Dr. Kuske, authors of the study were Christa Corn, M.D., a general surgeon and breast cancer surgery specialist practicing in Phoenix, Ariz.; Coral Quiet, M.D., and Salih Gurdalli, Ph.D. Dr. Kuske and Dr. Quiet are radiation oncologists with Arizona Oncology Services (AOS), a national leader in breast cancer treatment with locations throughout the greater Phoenix area. Dr. Gurdalli is a physicist at AOS. Dr. Corn said SAVI can provide therapy that is customized to each patient’s situation. “Anytime you can individualize therapy, you can give a patient better treatment,” she said.

SAVI does not require any advanced surgical techniques and can be placed in the surgeon’s office. The device is available in three sizes, with the smallest allowing placement in surgical cavities that are too small for the balloon brachytherapy device.

“It’s allowing us to do a more minimal operation that yields a great cosmetic result,” said Dr. Corn. “I’m really excited about SAVI because I think it’s going to allow more women to have brachytherapy. Women don’t need special surgeons with this device. If they live in an area where specialized breast surgery isn’t available, they’re still going to be able to get brachytherapy.”

Breast conservation therapy includes lumpectomy – the surgical removal of the cancerous tissue within the breast plus tissue immediately around the tumor – followed by radiation.

Radiation treatment after a lumpectomy has traditionally involved irradiation of the entire breast with an external beam. Whole breast irradiation exposes more healthy tissue to potentially harmful radiation, and involves a lengthy treatment course — five treatments a week over a six-seven week period.

SAVI delivers breast brachytherapy, which targets the tumor site from inside the breast. This approach is becoming a more widely used alternative to whole breast radiation, and typically is concluded after just five days.

Among its benefits, the SAVI applicator provides greater flexibility in delivering radiation, which may reduce radiation damage to the skin or chest wall.

About Cianna Medical
Cianna Medical, Inc. is a women’s health company dedicated to the innovative treatment of early-stage breast cancer. The company manufactures and markets the SAVI™ breast-brachytherapy device, 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.ciannamedical.com.