August 17, 2016 — Cianna Medical Inc. announced the company has received an additional U.S. Food and Drug Administration (FDA) 510(k) clearance for the Savi Scout radar localization system, allowing the reflector to be placed at the lumpectomy site up to 30 days prior to surgical removal. Scout, the first medical device to use radar in human tissue, is a tool for localizing and directing the removal of non-palpable breast lesions.
“The new clearance enabling reflector placement up to 30 days before surgery provides us even more flexibility with scheduling,” said Charles Cox, M.D. “As an early adopter and ongoing user of Scout, I’ve found the technology to be highly intuitive, easy to implement and a significant improvement over wire localization in terms of patient experience. Importantly, use of Scout also supports greater efficiency in the hospital with less wait time for both patients and physicians.”
Peer-reviewed data recently published in the July issue of Annals of Surgical Oncology demonstrated 100 percent surgical success, with significantly lower repeat surgery rates than those reported when using wire localization. In all cases where localization was performed, targeted lesions and reflectors were successfully removed without any observed reflector migration. In another key study finding, researchers concluded that the Scout reflector could be reliably detected up to 5 cm from the handpiece.
The study also demonstrated high clinician and patient satisfaction with Scout. Overall, physicians reported favorably on patient comfort, patient anxiety and overall patient experience, and a majority of physicians (85 percent) reported workflow improvement with the device compared with wire localization. On a scale of 1-5, where 3 was equal to wire localization, surgeons favorably rated ability to start cases earlier at 4.9, 4.4 for patient wait times and 4.4 for reduction in operating room (OR) scheduling delays. Radiologists and surgeons also reported a 4.1 for a better overall patient experience. Post-procedure survey data indicated that 97 percent of patients would recommend Scout to others.
The study also received the 2016 Scientific Impact Award at the Society of Breast Surgeons (ASBrS) Annual Meeting, recognition given annually to the clinical research presentation that is considered to have the greatest scientific impact on breast cancer care, as judged by surgeon attendees.
The Scout system features a reflector that is placed at the tumor site up to 30 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 radar 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 better surgical planning that may improve cosmetic results.
For more information: www.ciannamedical.com