WASHINGTON--An FDA advisory panel has recommended that the agency approve a new indication for a digital ultrasound system that would expand the role of ultrasound in breast disease.
WASHINGTON--An FDA advisory panel has recommended that the agencyapprove a new indication for a digital ultrasound system thatwould expand the role of ultrasound in breast disease.
Currently, ultrasound in breast disease is limited to its usein differentiating cystic from solid breast masses and guidingneedles during biopsies. The new indication would allow use ofhigh-resolution digital ultrasound after a suspicious mammogramto aid in differentiating benign from malignant breast lesions(see figures below).
If the Ultramark 9 High Definition Imaging (HDI) Digital UltrasoundSystem receives premarket approval for this use, it has the potentialto reduce the number of benign breast biopsies by as much as 35%,according to the manufacturer, Seattle-based Advanced TechnologyLaboratories.
The advisory panel recommended approval with two conditions: thatthe device be used only in lesions 1 cm or larger, unless studiesdemonstrate statistical significance in smaller lesions, and thatthe company provide training for clinical users in this new application.
The PMA was based on the findings of an international multicenterstudy involving more than 1,000 women with breast lesions whowere undergoing biopsy. Lesions were classified based on mammographyresults, then reclassified after an HDI ultrasound exam performedbefore breast biopsy.
The ultrasound exams were 99% accurate in identifying benign lesions,with only one misdiagnosis, and accurate in identifying breastcancers, the company said.