Cianna Medical, a firm based in Aliso Viejo, California, won FDA clearance for its SAVI SCOUT system to be used to tag breast cancer lumps up to thirty days prior to surgical removal. Typically, lumps are first identified and localized, with either a radioactive seed or a guidewire left behind to help get back to the exact spot during the lumpectomy. Guidewires protrude from the breast and radioactive seeds emit ionizing radiation, both methods having their own limitations.
The SAVI SCOUT instead relies on a tag that reflects light and electromagnetic radiation, but that doesn’t produce ionizing radiation. A pen-like device connected to the control unit is used to spot the tag’s precise location within the breast. It emits both an infrared light and a radiofrequency signal, while detectors within detect the returning signals. Using the system, a surgeon can quickly reach the target lump to remove it, while grabbing the reflector right along. The detector is finally used to confirm that the reflector is among the excised tissue to make sure it didn’t stay back in the body.
From Cianna’s announcement:
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%) 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% of patients would recommend SCOUT to others.
Product page: SAVI SCOUT…
Source: Cianna Medical…