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The BIP VacuFlash® Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The BIP VacuFlash® Biopsy System is a mechanical device that may be used with imaging quidance (such as ultrasound, X-Ray, stereotaxy, CT, or MR) to provide breast tissue samples for histologic examination with partial or complete removal of the imaged abnormality. The VacuFlash® Biopsy System consists of three major components: a disposable trocar tipped needle with a vacuum cylinder, a disposable introducer with stylette, and a reusable device housing containing the control module, touch pad with control buttons and LEDs indicating device status, and vacuum/air pressure generators. The disposable needle/vacuum cylinder will be available in several different lengths. A battery recharger/table top stand is the only provided accessory. Mounting brackets to attach the VacuFlash® Biopsy System to the Fischer Mammotest® and to the Lorad stereotactic tables are optional accessories. In addition, brackets to attaché the VacuFlash to the Siemens stereotactic mammography and to the Siemens MR Mammography Biopsy systems are available. Sterile bushings for the above devices, including CytoGuide stereotactic and GE DMR Mammography systems are also available. The needle inner cannula incorporates a distal sampling with sharpened edges. During the biopsy procedure, tissue is vacuum aspirated into the inner cannula and cut using both the sampling window edges and the rotating edge of the outer cannula. Once the needle is removed from the patient's body, the sampling window is opened and the specimen removed. Tissue samples may be collected in radial order so that when imaging guidance is used, sampling positions may be retrospectively correlated with the imaging display.