TORONTO - PET developer Naviscan is starting shipments of an image-guided biopsy attachment to its PEM Flex Solo II positron-emission mammography (PEM) system, the San Diego company told attendees at this week's SNM meeting.
First shown at the 2008 RSNA show, the device enables clinical users to biopsy lesions detected on the PEM scanner. Previously, users had to send patients to another imaging modality, such as second-look ultrasound or breast MRI, to undergo image-guided biopsy.
With the attachment, PEM users can perform a scan and conduct a biopsy immediately if a suspicious area is detected. A needle guide with trocar is first inserted into the breast, and a germanium-tipped radioactive probe is guided to the lesion site to confirm placement.
Any one of three commercially available vacuum-based biopsy devices can then be inserted to remove a tissue sample, and samples can be imaged immediately to confirm that cancerous tissue was removed. The biopsy site can also be scanned again to confirm that no "hot" areas remain in the breast, according to the company.
Naviscan is shipping the first PEM biopsy device as part of a newly purchased system this month, and is planning on offering the device to the 40 systems in its installed base later this month. Naviscan estimates that the device adds about 8% to the cost of a new Naviscan unit.
The company believes that adding a biopsy capability should do for PEM what it did for breast MRI in terms of making the procedure easier to perform in the clinical setting, according to Naviscan President and CEO Paul Mirabella.
Related Reading
Naviscan enters licensing agreement, June 5, 2009
Naviscan ends trial enrollment, gets FDA OK, December 19, 2008
PEM may reduce false-positive reports, December 3, 2008
Road to RSNA, Molecular Imaging, Naviscan, October 28, 2008
Naviscan nets NYC customer, August 13, 2008
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