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The 14G CORMARK™ Biopsy Site Identifier is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.

The 14G CORMARK™ Biopsy Site Identifier is composed of a bioresorbable collagen plug embedded with a titanium non-resorbable radiopaque marker or clip. At the completion of a breast biopsy procedure, the marker is deployed into the biopsy cavity, using a stainless steel syringe-like applicator with 1 cm markings to aid in needle placement. The marker is intended to help relocate the biopsy site for any subsequent intervention or diagnosis. The collagen slowly absorbs and the titanium radiopaque marker is left behind as the permanent identifier of the biopsy site.

The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for histologic examination with partial or complete removal of an imaged abnormality. The extent of an histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of an imaged abnormality does not predict the extent of removal of its 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 Caris™ MiniTome Biopsy Instrument is percutaneous device that removes a single intact biopsy sample. The Caris MiniTome is hand-held and may be used with common imaging modalities such as ultrasound and upright mammography. The system consists of imaging modulities outchation needle, which also acts as a guidewire, the Caris™ MiniTome Biopsy Instrument, and a control module with flexible drive cable. The Caris™ MiniTome Biopsy Instrument consists of a hand piece that has a stainless steel rno outlo - mirih a tungsten cutting wire loop. A guidewire extension runs through the central lumen of the device and attaches to a localization needle. The Caris™ MiniTome is placed over a localization needle, which is placed through or adjacent to the targeted tissue site. The localization needle has a braided mesh at the distal tip that is deployed to anchor the needle in place. Once the MiniTome has been guided over the localization needle and is in position, the start button on the controller is pressed. This activates a controller sequence which first allows RF energy from a standard electrosurgical generator to pass through the cutting wire, deploys the cutting wire into a loop, rotates the distal tip and cutting wire a predefined number of rotations, then shuts off the RF current from the electrosurgical generator. Thus, the cutting loop automatically rotates through the desired excision zone to resect the tissue sample. An integral "Python" sleeve, which is a component of the Caris™ MiniTome, is manually advanced to encapsulate the excised specimen. Then the device and specimen is removed through the percutaneous incision.