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.

Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion.

Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery.

Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement.

Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target

Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise

Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy

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)