Percutaneous Excision Trial
Percutaneous Excision Trial
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