Percutaneous Excision Trial

Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.

To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.

Inclusion Criteria:

• Patient must be a female at least 18 years of age at the time of Intact BLES biopsy
• Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis

Exclusion Criteria:

• Patients who have pre-pectoral breast implants
• Patients who have implantable devices such as pacemakers and defibrillators
• Patients who are pregnant or lactating
• Patients in whom the device is contraindicated
• Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection