Breast tumor resection typically comprises of two separate procedures to first localize the tumor and then to actually remove it. Once a physician identifies tumor location, a guidewire or a radioactive seed is positioned at the center of the tumor to help navigate to the therapy site during the resection by surgeon. Guidewires are not very pleasant to have sticking out of the breast while waiting for the resection, while radioactive tags can potentially create their own problems and come with special protocols and regulations that normally accompany radioactive materials. A new system called SAVI SCOUT from Cianna Medical(Aliso Viejo, CA) has just been approved by the FDA that allows the placement of a non-radioactive seed that can be quickly spotted even days later using a special probe.
The seed is actually a simple reflector that bounces light and electromagnetic waves that come upon it. The SAVI SCOUT device features a probe that emits infrared light and an electromagnetic field, as well as detectors that can spot the returning signal coming from the seed. This allows the seed to be placed up to seven days prior to a resection and to quickly navigate to it once the patient is sedated. The tumor is removed with the help of the probe and the excised tissue is scanned using the same probe to confirm that the reflecting seed is safely outside the body.
Here are some details of early results from a pilot study of the device according to Cianna Medical:
Results from a pilot study evaluating successful placement, localization and retrieval of the SAVI SCOUT were presented as part of the late breaking scientific sessions at San Antonio Breast Cancer Symposium today. The study included 24 patients, and resulted in 100% surgical success using SAVI SCOUT. In all cases, the target tissue and reflector were successfully removed; there were no incidents of reflector migration or adverse events. Pathology reports showed clear margins in comparable numbers to radioactive seed location.
The pilot study with SAVI SCOUT is ongoing at the University of South Florida College of Medicine and the Nashville Breast Center. Cianna Medical plans to bring the technology to additional medical centers over the course of 2015 and will be supporting product uptake with professional education and ongoing reporting on data and case studies from the clinical program.