Magseed Pro(R)/ Sentimag(R) Gen3

Summary

The purpose of this study is to provide prospective evidence that the Magseed Pro® marker /Sentimag® Gen3 system is safe and effective for marking A. suspicious/biopsy-proven positive axillary lymph nodes; and B. soft tissue lesions including cancer and pre-cancerous change in the breast

Eligibility

Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Participant is aged 18 years or older at the time of consent.
* Patients requiring breast lesion/axillary node marking and excision

Exclusion Criteria:• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period. A pregnancy test is required for all women of childbearing potential within 7 days before enrolment.

* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical trial or to comply with follow up requirements, or impact the scientific soundness of the clinical trial results
* Known hypersensitivity to Nitinol
* Subject has current active infection at the implantation site in the breast (per investigator discretion)

Conditions2

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