Cianna Medical's SAVI SCOUT surgical guidance system gets FDA clearance

Late-Breaking Data From Pilot Study on New Electromagnetic Wave Device For Tissue Targeting During Breast Conservation Surgery at San Antonio Breast Cancer Symposium

Cianna Medical Inc. announced today U.S. Food and Drug Administration clearance for the SAVI SCOUT^® surgical guidance system, a novel technology that uses real-time audible and visual indicators to give surgeons a precise way to target tissue during lumpectomy and excisional biopsy procedures. SAVI SCOUT is the newest addition to the Cianna Medical family of products, which also includes the innovative SAVI^® breast brachytherapy applicator.

The SAVI SCOUT surgical guidance system uses non-radioactive, electromagnetic wave technology to detect a reflector that can be placed in the target tissue up to seven days prior to surgery. During the procedure, the surgeon then uses the SAVI SCOUT handpiece, which emits infrared light and electromagnetic waves, to locate the reflector and plan the incision. The surgeon then removes the reflector and the target tissue.

“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, Tampa, Fla. “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 SAVI SCOUT were presented as part of the late breaking scientific sessions at San Antonio Breast Cancer Symposium today. The study, which included 24 patients, resulted in 100% surgical success using SAVI SCOUT. 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 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, 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 market leading 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.”