Search Results

The TraxyLoc™-1 System is a near-real time, image-guided accessory to mammography equipment designed to stabilize a patient's breast and assist a qualified physician in performing a pre-surgical, stereotactic needle localization procedure to target one or more mammographically previously discovered abnormalities for subsequent biopsy or other procedures.

The TraxyLoc™-1 System is designed for, pre-surgical use in a stereotactic needle localization procedure to target mammographically previously discovered breast abnormalities. The device provides breast stabilization and needle guidance for accurate placement of localization needles at positions of suspected abnormalities in the breast. The device is intended for appropriately trained and qualified physicians, radiologists, and radiology/medical technicians who have previously performed manual and/or stereotactic needle localizations procedures. The TraxyLoc™-1 System stabilizes the breast in a compression unit which is attached to the mammography equipment. After obtaining two images sterentactically (horizontal and vertical images) the previously identified breast artifact is identified and located on the Overlay Grids. The view orientation and artifact location data is then entered into the Traxalign™ software and the system settings for performing a needle localization are obtained. The localization needle is southings to personally holder. The needle holder is then placed onto the guidance frame as per the software directions. The needle is inserted into the breast as per a typical manual needle localization procedure. At least one confirmatory mammography image should be taken to ensure the position of the needle.