Cianna Medical said today that the Savi Scout reflector, part of its system for wire-free breast tumor localization, won FDA clearance as the first non-radioactive implant without a restriction on the length of time that the reflector can remain in a patient’s breast.
The new clearance means that doctors can place Scout to mark a biopsy or lumpectomy site and not be constrained by a maximum implant time, the Aliso Viejo, Calif.-based company said. The Scout reflector also won’t interfere with MRI studies, so doctors aren’t restricted in the types of imaging modalities they can use with their patients.
The Scout reflector device is smaller than a grain of rice and remains inactive until activated by the Scout guide, according to Cianna Medical.
“Achieving this milestone significantly advances Cianna Medical’s mission to reduce the burden breast cancer treatment places on women and their families. I applaud the vision of all our physicians and health systems who are leading the way in offering a new standard of care in breast tumor localization,” president & CEO Jill Anderson said in prepared remarks.
“Scout has become the most precise and broadly applicable non-wire localizing system in the industry and more than 170 leading medical centers across the United States have adopted Scout radar breast localization and surgical guidance system as an alternative to placing wires on the day of surgery.”
“Our health system has made wire-free radar localization our new standard of care for breast tumor localization,” Dr. Nina Vincoff, chief of breast imaging at Northwell Health, added. “Our patients have indicated high satisfaction with the procedure. This new FDA clearance will continue to enhance the patient experience by offering more options and flexibility for physicians to implant the reflector based on patient treatment needs.”