April 20, 2016 — Cianna Medical Inc. announced new clinical data evaluating the Savi Scout breast localization and surgical guidance system. Results demonstrating high rates of clinical efficacy, intra-operative retrieval and surgical success rates were presented in an electronic poster session at the Society of Breast Imaging/American College of Radiology (SBI/ACR) Breast Imaging Symposium, April 7-10.
Savi Scout, a U.S. Food and Drug Administration (FDA)-cleared tool for localizing and directing the removal of non-palpable breast lesions, became available in late 2015.
Results from the investigator-initiated trial of 154 patients demonstrated a 100 percent surgical success rate using Scout, with a low re-excision rate that is in line with rates reported for intraoperative ultrasound. In all cases where localization was performed and data are complete, targeted lesions and reflectors were successfully removed without any observed reflector migration.
“These data confirm previous findings demonstrating that real-time surgical guidance with Scout is a clinically reproducible, safe and effective technique for directing the removal of non-palpable breast lesions with no wires or radioactive materials,” said Jiyon Lee, M.D., a presenting study investigator and assistant professor in the Department of Radiology at NYU Langone Medical Center.
Hildegard Toth, M.D., study co-investigator and associate professor in the Department of Radiology at NYU Langone, added, “In our studies, Scout demonstrated an additional benefit of decoupling the localization and surgical procedures, which may result in improved patient scheduling and work flow.”
The study also examined clinician and patient satisfaction with Scout. Radiologists favorably rated the overall patient experience at 4.1 on a scale of 1-5, where 3 was seen as Scout having equal favorability to wire localization. Using the same scale, surgeons favorably rated ease of localization at 3.9 and ability to start cases earlier at 4.9. Post-procedural survey data indicated that 97 percent of patients would recommend Scout to other patients.
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.
For more information: www.ciannamedical.com