SenoMark Biopsy Site Marker - Marker, lesion localization, implantable

Intended purpose

An implant used to radiographically and sonographically mark breast tissue during a percutaneous breast biopsy procedure.

Functional description

A disposable applicator containing 3 resorbable polyglycolic acid (PGA) pads, the centre pad containing a stainless steel wireform. A polyethylene glycol (PEG) push pad is present at the end. The wireform is intended for long term radiographic marking of the biopsy site. The pads are visible via ultrasound for approx. 3 weeks and resorbed in approx. 12 weeks. The applicator provides access to the biopsy site and is used to deploy the pads into the biopsy cavity.