Introducing LOCalizer, the wire-free breast lesion system from Hologic.
The LOCalizer™ wire-free guidance system is designed to mark and guide to non-palpable breast lesions using a miniature radiofrequency identification (RFID) Tag. Each Tag has a unique identification number that is displayed on the reader and can be placed in the breast at any time prior to or during the day of surgery. A recent case series has shown that LOCalizer™ may be able to reduce positive margin rates with lumpectomy due to unique feature of reading distance from the tag*.
Maximize schedule flexibility without the hassle of complex regulations associated with radioactive seeds.
The LOCalizer system features:
- Miniature RFID tag with unique ID # pre-loaded in a needle applicator
- Single-use surgical probe with small, ~8mm tip
- Portable handheld reader that can be placed in the sterile field**
Wire-free Miniature RFID Tag
At approximately 11mm long and 2mm in diameter, each Tag includes a unique identification number displayed by the reader and a polypropylene cap designed to prevent migration in tissue. The Tag is visible under X-ray and ultrasound and has no contraindication for patients with nickel allergies.
Single-Use Sterile Probe
The Surgical Probe is a pencil-sized, single-use sterile probe that will guide the surgeon towards the Tag during the operation.
The 8mm diameter of the probe allows for small incisions.
Portable Handheld Reader
The handheld Reader displays the distance to the Tag in millimeters and the Tag’s ID number on a bright screen, making it easy to read during the procedure. The LOCalizer™ system can read the tag from at least a 60mm distance and is designed to function without interference from the other equipment in the OR.
* N = 50 patient, single arm pilot study. DiNome M et al. Microchipping the breast: an effective new technology for localizing non-palpable breast lesions for surgery. Poster presentation, Society of Surgical Oncology annual meeting, Mar 27-30, 2019.
** When bagged in sterile drape (included in the system).
FDA 510(k) clearance K181692 (link)