Cianna Medical said it reached a new milestone, winning FDA clearance for new surgical guidance tech designed to boost precision in breast biopsies and lumpectomies. Plans call for a slow rollout, with a gradual expansion in 2015 beyond 2 medical centers in Florida and Tennessee currently involved in a pilot study, the company said.
"We believe it has the potential to reduce surgical delays, improve patient satisfaction and optimize surgical planning," CEO Jill Anderson said in prepared remarks.
The Savi Scout surgical guidance system is designed to produce audible and visual indicators surgeons can use to tag cancerous tissue during lumpectomy and biopsy procedures.
The surgeon uses a hand piece that emits infrared light and electromagnetic waves to locate a reflector placed in target tissue as long as a week before surgery. After reaching the surgical bulls-eye, the surgeon takes out the target tissue and the reflector, according to the company. No radiation is involved. It is designed for breast conservation surgery, where surgeons remove all detectable cancer cells.
Cianna, which is based in San Antonio, Texas, touts its technology as a big boost in care over existing standard to locate non-palpable breast lesions.
One 20-year-old procedure is known as "wire localization," where a radiologist inserts a wire into the breast in order to guide the surgeon to the target tissue. According to the company, wire placement and surgery can take several hours, cause patient discomfort and is cumbersome to schedule. There’s also the implanting of radioactive seeds, but it involves major regulatory requirements and risks.
Separately, Cianna said, it presented results from a pilot study that evaluated placing, localizing and retrieving the Savi Scout at the San Antonio Breast Cancer Symposium. The study involved 24 patients and all were surgically successful, the company said. A pilot study remains ongoing at the University of South Florida College of Medicine and the Nashville Breast Center.
Cianna said that as it expands to more medical centers in 2015, it will also support the product with professional education and dissemination of data and case studies from its clinical program.