Cianna Medical, Inc. has received an additional 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, which uses radar in human tissue, is a tool for localizing and directing the removal of non-palpable breast lesions.
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 SCOUT 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 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.
SCOUT has undergone rapid adoption and is now in use at more than 50 medical centers across the U.S.
“Extending the timeframe between tumor localization and surgical intervention has the potential to improve scheduling flexibility for patients, physicians and health systems, further supporting the use of radar as a desirable platform technology for tumor localization,” said Jill Anderson, president and CEO of Cianna Medical.