April 28, 2016
- Oral presentation at American Society of Breast Surgeons Annual Meeting highlights 100 percent surgical success and high patient and provider satisfaction –
DALLAS – April 14, 2016 – Cianna Medical, Inc. today announced leading breast surgeon Pat Whitworth, M.D. will present data demonstrating that the SAVI SCOUT® breast localization and surgical guidance system was associated with a 100 percent surgical success rate, high clinical reproducibility and favorable clinician and patient satisfaction. Study results will be discussed during an oral presentation at the American Society of Breast Surgeons (ASBrS) 17th Annual Meeting, taking place from April 13-17.
SAVI SCOUT, an FDA-cleared tool for localizing and directing the removal of non-palpable breast lesions, became available in late 2015. The technology has undergone rapid adoption and is now in use at more than 50 medical centers across the U.S.
Results from the investigator-initiated trial of 154 patients demonstrated a 100 percent surgical success rate using SCOUT, with significantly lower repeat surgery rates than those reported when using wire localization. In all cases where localization was performed and data are complete, targeted lesions and reflectors were successfully removed without any observed reflector migration.
The study also demonstrated high clinician and patient satisfaction with SCOUT. On a scale of 1-5, where 3 was equal to wire localization, surgeons favorably rated ability to start cases earlier at 4.9 and 4.3 for reduction in OR scheduling delays. Using the same scale, radiologists rated patient comfort, patient anxiety and overall patient experience better than wire localization at 3.7, 3.8 and 4.1 respectively. Post-procedure survey data indicated that 97 % of patients would recommend SCOUT to other patients.
“These data reinforce earlier findings confirming that real-time surgical guidance with SCOUT is an extremely accurate technique for directing the removal of non-palpable breast lesions,” noted Pat Whitworth, M.D., a study investigator and breast surgeon from the Nashville Breast Center. “Furthermore, we now have strong evidence that the use of SCOUT is reproducible in multiple real-world clinical settings and is associated with high patient and physician satisfaction.”
Rochelle Colon, a patient who has undergone two separate lumpectomy procedures, added “When I was first diagnosed with breast cancer, my doctor used wire localization. This time around, 15 years later, SAVI SCOUT was used for the localization procedure. The tumor was much smaller, and so it was not easy to find. That little reflector is a miracle! With SCOUT, my doctor was able to pinpoint the tumor immediately.”
The study was conducted at 11 sites, with 17 surgeons and 24 radiologists contributing. Participating centers include: University of South Florida Breast Health, Nashville Breast Center, Baylor Regional Medical at Plano, Cancer Centers of Colorado, Hackensack University Medical Center, UC Irvine Health Pacific Breast Care Center, Medical Center of Plano Complete Breast Care, Morton Plant Mease Hospital, New York University Langone Medical Center, Pink Lotus Breast Center and Texas Breast Specialists.
“These promising results underscore why we chose micro-impulse radar as the platform technology for tumor localization,” said Jill Anderson, President and CEO of Cianna Medical. “SCOUT is a zero radiation and wire-free solution that has demonstrated the potential to drive value by reducing costs and improving patient outcomes.”
About SAVI SCOUT®
The FDA-cleared SCOUT system features a reflector that is placed at the tumor site up to seven days before a lumpectomy or surgical biopsy. During the procedure, the surgeon scans the breast using the SCOUT handpiece, which emits infrared light and a micro-impulse signal to detect the location of the reflector. Real-time audible and visual indicators assist the surgeon in accurately locating the reflector, along with the target tissue. This higher level of localization precision allows the surgeon to plan a surgical approach that may result in a better cosmetic outcome.
About Breast Conservation Surgery
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 percent 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 (WL). With this procedure, a wire is inserted into the breast by a radiologist to guide the surgeon to the target tissue. The most common challenges reported with current localization techniques include scheduling and workflow, surgical planning and guidance, high re-excision rates and a sub-optimal patient experience.