A pair of studies examining utilization of Cianna Medical’s SAVI breast brachytherapy device has reported positive clinical experiences, according to the Aliso Viejo, Calif.-based firm.
SAVI is a single-entry, multi-catheter device that delivers radiation as part of breast conservation therapy.
A study co-authored by Arizona Oncology Services (AOS) of Phoenix reports outstanding early experiences with the SAVI applicator -- particularly for minimal side effects and the device’s potential to increase the number of women eligible for shorter breast cancer radiation treatment.
The retrospective study evaluated the first 102 patients to undergo therapy with the SAVI device, making it the largest clinical evaluation of the SAVI applicator to date, Cianna said.
Researchers examined several parameters to assess the device’s performance, including dosimetry, seroma formation and infection rates. Almost half of the evaluated patients were not eligible for other single-entry breast brachytherapy devices because of skin spacing or breast size.
AOS was the first medical facility in the United States to offer SAVI as an option for breast conservation therapy.
The research was presented as a scientific poster at the 2008 Breast Cancer Symposium, held earlier this month in Washington, D.C. The study was also co-authored by physicians from the department of radiation oncology at University of California San Diego and the Breast Care Center of the Southwest in Phoenix.
A similar study was conducted at Fort Myers, Fla.-based 21st Century Oncology, and was presented as a scientific poster at the American Society for Therapeutic Radiology and Oncology (ASTRO) in Boston this week.
The group found that the SAVI application delivered excellent cosmetic results with minimal side effects, for women who had not qualified for breast conservation therapy using a previously available balloon device.
They reported no incidence of potential side effects such as seroma, pigmentation change, fibrosis or infection.