Technology | December 16, 2014

FDA Clears Cianna Medical SAVI Scout Breast Surgical Guidance System

System provides real-time audiovisual indicators for precise tissue targeting while increasing patient comfort

Cianna Medical, SAVI Scout, breast surgical guidance system

Photo courtesy of Cianna Medical

December 16, 2014 — Cianna Medical Inc. received U.S. Food and Drug Administration (FDA) clearance for the SAVI Scout surgical guidance system. The technology uses real-time audible and visual indicators to give surgeons a precise way to target tissue during lumpectomy and excisional biopsy procedures.

"The SAVI Scout surgical guidance system has a high degree of utility and we believe the system will enable us to improve care for our breast conservation surgery patients," said Charles E. Cox, M.D., professor of surgery and McCann Foundation endowed professor of breast surgery, University of South Florida College of Medicine. "I found the system to be highly intuitive and expect that we will see fairly rapid uptake of the SAVI Scout in breast centers across the country."

Results from a pilot study evaluating successful placement, localization and retrieval of the device were presented as part of the late breaking scientific sessions at the San Antonio Breast Cancer Symposium. The study, which included 24 patients, resulted in 100-percent surgical success. In all cases, the target tissue and reflector were successfully removed; there were no incidents of reflector migration or adverse events. Pathology reports showed clear margins in comparable numbers to radioactive seed location.

The SAVI Scout includes an electromagnetic wave reflective device (or reflector), a hand piece and a console. A common method for identifying nonpalpable lesions for surgery is wire localization, which requires a radiologist to place a wire inside the breast to identify the target tissue, and the patient may have to wait for hours with the wire in place that can be unpleasant for women. There is an alternative called radioactive seed localization, but it requires radioactive materials.

"We believe [it] provides two major advantages: First, the reflector can be comfortably placed several days prior to surgery, on the day of surgery by a radiologist or in the operating room by a surgeon," Pat Whitworth, M.D., director of the Nashville Breast Center, said. "Second, the hand piece can be used with retractors so, as the dissection proceeds, we receive immediate, real-time guidance for the lumpectomy."

For more information: www.ciannamedical.com

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