Cianna Medical Wins FDA Nod for Breast Tumor Device

Results from a pilot study evaluating successful placement, localization and retrieval of the SAVI Scout recently showed 100 percent surgical success in all 24 patient participants. In each case, the target tissue and reflector were successfully removed; there were no incidents of reflector migration or adverse events.

The goal in breast-conservation surgery is to remove all detectable cancer cells. Of the estimated 174,000 women who have breast conservation surgery each year, approximately 30% will require repeat surgery because cancer cells are not completely removed during the first procedure. 

Developed more than 20 years ago, the standard preoperative technique for localizing non-palpable breast lesions is wire localization. With this procedure, a wire is inserted into the breast by a radiologist to guide the surgeon to the target tissue. The time between wire placement and surgery can be several hours and, in addition to potentially being unpleasant for women, the process presents scheduling challenges for surgeons, radiologists and hospital staff.

Radioactive seed localization (RSL) was developed as an alternative to wire localization. Despite some proven advantages, the adoption of RSL has been impacted by considerable regulatory requirements and precautions for the safe handling of radioactive materials.

“We believe that SAVI Scout 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. Second, the SAVI Scout handpiece can be used with retractors so, as the dissection proceeds, we receive immediate, real-time guidance for the lumpectomy,” said Pat Whitworth, M.D., director, Nashville Breast Center in Nashville, Tenn. “We are finding SAVI Scout eliminates the need to stop for intraoperative ultrasound; we can now use imaging only before and after the resection. I expect it’s going to be a welcome advance for surgeons and patients.

The pilot study with SAVI Scout is ongoing at the University of South Florida College of Medicine and the Nashville Breast Center. Cianna Medical plans to bring the technology to additional medical centers over the course of 2015 and will be supporting product uptake with professional education and ongoing reporting on data and case studies from the clinical program.

“Cianna Medical adheres to a patient-centric mission and the introduction of SAVI Scout is an important milestone in our ongoing commitment to delivering innovative products that improve patient outcomes and quality of life,” said Jill Anderson, CEO, Cianna Medical. “SAVI Scout is an optimal addition to our SAVI family and we believe it has the potential to reduce surgical delays, improve patient satisfaction, and optimize surgical planning – all without radioactive components. We look forward to bringing this new technology to the breast cancer community.”

Cianna Medical Inc. develops breast cancer treatment products. The company manufactures and markets the SAVI breast brachytherapy applicator, a device that allows for precise sculpting of a radiation dose after lumpectomy surgery. To date, more than 20,000 women have been treated with the SAVI brachytherapy applicator.