SecurMark for Eviva - Marker, lesion localization, implantable

Intended purpose

Hologic SecurMark Biopsy Site Markers are indicated for the permanent radiographic marking of sites in soft tissue. The Hologic SecurMark Biopsy Site Markers are used following breast biopsy procedures performed with the Eviva® Breast Biopsy System or Brevera® Breast Biopsy System. The SecurMark markers provide the user with the ability to mark the location of the cavity where the breast biopsy was performed. The markers are placed at the biopsy site under stereotactic guidance, depending on which type of biopsy device is used.

Functional description

The SecurMark biopsy site marker is a sterile, single patient use device comprised of a single, biocompatible titanium marker surrounded by a bioabsorbable suture-like material and a deployment device. The deployment device is a hand-held device that delivers the marker from the distal tip. The deployment device consists of a rigid cannula, handle, rigid push rod, plunger, spacer and tip protector. The marker is located at the distal end of the deployment device.