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.
Currently, ultrasound in breast disease is limited to its use
in differentiating cystic from solid breast masses and guiding
needles during biopsies. The new indication would allow use of
high-resolution digital ultrasound after a suspicious mammogram
to aid in differentiating benign from malignant breast lesions
(see figures below).
If the Ultramark 9 High Definition Imaging (HDI) Digital Ultrasound
System receives premarket approval for this use, it has the potential
to reduce the number of benign breast biopsies by as much as 35%,
according to the manufacturer, Seattle-based Advanced Technology
The advisory panel recommended approval with two conditions: that
the device be used only in lesions 1 cm or larger, unless studies
demonstrate statistical significance in smaller lesions, and that
the company provide training for clinical users in this new application.
The PMA was based on the findings of an international multicenter
study involving more than 1,000 women with breast lesions who
were undergoing biopsy. Lesions were classified based on mammography
results, then reclassified after an HDI ultrasound exam performed
before breast biopsy.
The ultrasound exams were 99% accurate in identifying benign lesions,
with only one misdiagnosis, and accurate in identifying breast
cancers, the company said.