Faxitron has been awarded exclusive worldwide distribution rights for Health Beacons' RFID (radio frequency identification) breast lesion localization system, the LOCalizer, currently pending FDA 510(k) clearance.
The LOCalizer has been designed to provide a more accurate and effective approach than the wire localization procedure that is the current standard of care for localizing non-palpable breast lesions.
Fifty percent of all breast tumors are non-palpable at diagnosis making them difficult for surgical removal by touch alone. Wire localization employs a wire with a barbed end to mark the spot of the lesion for removal.
This procedure has many well-known challenges and often leads to surgery delays and cancellations, unsuccessful procedures, and added stress for patients. Radioactive Seed Localization (RSL), has been introduced to improve upon the wire localization technique but it has had limited adoption primarily because of the stringent radioactive material handling and monitoring regulations.
Instead of wires or radioactivity, the LOCalizer marks the lesion with a miniature radio frequency Tag that provides guidance to the surgeon through the use of a mobile handheld reader. Each Tag is encased in an anti-migratory sheath, has a unique identification number and is designed to be implanted in the breast up to 30 days before the surgery.
Other key features include: a probe integrated with the reader, suitable for both sterile and non-sterile environments; an attachable, sterile, single-use surgical probe; an integrated LED screen for display of the distance to the Tag and an audible tone which helps to guide the surgeon during the procedure.
"Faxitron is thrilled about our new partnership with Health Beacons," said Faxitron CFO & COO Donogh O'Driscoll. "The LOCalizer is poised to become the new standard of care in surgical localization of non-palpable breast lesions.
“Just as Faxitron pioneered and developed the market for intraoperative specimen radiography, we are excited to champion Health Beacons' technology for localization. Pending 510(k) clearance of the LOCalizer by the FDA, we look forward to further expanding our sales and clinical applications teams to support our market development program both in the United States and globally through our distribution channels."
Commenting on their new partnership with Faxitron, Health Beacons CEO Nancy Confrey said, "we are delighted to be partnering with a company with such a highly valued brand in the breast surgery market. The Health Beacons team is excited to be working with Faxitron to establish the LOCalizer as the new standard for localization."
Faxitron is the industry leader in cabinet x-ray systems for specimen radiography, research, and NDT applications. For more than 50 years, Faxitron has defined cabinet x-ray by continuing to develop best in class x-ray sensor technology and innovative systems.