A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.

Inclusion Criteria:

• Female
• Age ≥ 18 years
• BIRADS ≤ 5, as initially imaged
• Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used

Exclusion Criteria:

• Male
• Subjects with subglandular (pre-pectoral, or "single plane") breast implants
• Subjects with electronic implantable devices (such as pacemakers and defibrillators)
• Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed