Contraindications; Device Description - Hologic eviva Bedienungsanleitung

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Eviva Breast Biopsy Device
Instructions for Use (IFU)
Please read all information carefully. Failure to properly follow the instructions may lead to
unintended consequences.
Important: This package insert is designed to provide instructions for clinical use (IFU) for
®
the Eviva breast biopsy device to be used with the ATEC breast biopsy and excision system
console. It is not a reference to surgical techniques.
Indications
The Eviva breast biopsy device is indicated to provide breast tissue samples for diagnostic
sampling of breast abnormalities under stereotactic breast biopsy guidance. The Eviva
device 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 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 procedure.

Contraindications

The Eviva device is for diagnostic use only and is NOT indicated for therapeutic use. The
Eviva device is contraindicated for those patients who, based on physician's judgment,
may be at increased risk or develop complications associated with core removal or biopsy.
Patients receiving anticoagulant therapy or who may have bleeding disorders may be at
increased risk of procedural complications.

Device Description

The Eviva device is a vacuum-assisted biopsy device which is used to remove breast tissue
in a minimally invasive manner using stereotactic imaging. The Eviva device is designed for
biopsy and diagnosis only. The device is NOT intended to be used outside the standards,
specifications and limitations as outlined in this IFU and other related materials. The device
is for single patient use and the entire device is fully disposable. The device primarily
consists of a hollow needle with a side aperture and a sharpened inner cannula that rotates
at high speeds and extends across the aperture to acquire targeted tissue. Throughout this
process, vacuum is created inside the device to assist in pulling tissue into the aperture.
Saline is supplied through the device to lavage the cavity and deliver tissue to the tissue
filter. An introducer system, specifically designed for use with the Eviva device, is included
with the device. This introducer system maintains access to the targeted area of interest and
allows for deployment of a biopsy site marker.
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