Device Dossier

SenoMark Ultra Breast Tissue Marker - Titanium - Marker, lesion localization, implantable

Device Dossier for SenoMark Ultra Breast Tissue Marker - Titanium - Marker, lesion localization, implantable (Marker, lesion localization, implantable,…

Intended purpose

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

Functional description

Disposable applicator with 3 resorbable PGA pads, each containing a ribbon shaped Titanium wireform with an interwoven PVA polymer.Pads assist in accurate placement of the marker until they are resorbed in approx 12 weeks.A polyethylene glycol push pellet is present at the end.The wireform is intended for long-term radiographic marking of the biopsy site.The PVA polymer is intended for long-term sonographic marking of the biopsy site.Applicator fits in a biopsy probe to access the body cavity.

TGA Public Summary