Cianna Medical’s Breast Tissue Surgical Guidance System Gets FDA Green Light

Aliso Viejo, Calif., devicemaker Cianna Medical has received FDA clearance for its Savi Scout surgical guidance system, which uses real-time audible and visual signs to help surgeons target tissue during lumpectomy and biopsy removal procedures.

The device includes a reflector placed in the target tissue up to seven days before surgery and nonradioactive, electromagnetic waves, which detect the reflector during the actual procedure. A hand-held instrument emits infrared light when it is over the reflector, helping the surgeon pinpoint the incision. The surgeon then removes both the reflector and the target tissue, Cianna explains.

In a pilot study to evaluate placement, localization and retrieval of the device, surgeons reported 100 percent success using Savi Scout, the company reports. In all 24 cases, the reflector and tissue were successfully removed, there were no adverse events and pathology reports showed clear margins in comparable numbers to radioactive seed location. The study is ongoing.

Savi Scout builds on the company’s patient-centric product line, which also includes the Savi breast brachytherapy applicator. “It has the potential to reduce surgical delays, improve patient satisfaction, and optimize surgical planning—all without radioactive components,” says Cianna CEO Jill Anderson.

According to the company, of the roughly 174,000 women who undergo breast conversion surgery each year, nearly 30 percent require repeat surgery because cancer cells weren’t completely removed the first time. — Kellen Owings

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