Magseed Magnetic Marker Localization

A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization

The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.

This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.

Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.

The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.

After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.

Inclusion Criteria:

• Subjects with a breast lesion requiring image-guided localization prior to excision.
• Subjects aged 18 years or more at the time of consent.

Exclusion Criteria:

• The subject is pregnant or lactating.
• Subject has pacemaker or other implantable device in the chest wall.
• Subject has current active infection at the implantation site in the breast (per investigatordiscretion)