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 Laboratories.
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.