July 18, 2013
by Carol Ko , Staff Writer
With the announcement of Siemens’ U.S. Food and Drug Administration clearance for its elastography product, Virtual Touch, it seems elastography is gaining momentum in the U.S. market.

The product has been available outside the U.S. since 2008.

Elastography works by measuring tissue stiffness to detect tumors, which are on average 5-28 times stiffer than healthy surrounding tissue. The technology provides crucial additional information for physicians, giving them additional diagnostic criteria to help them arrive at a more accurate conclusion around suspicious lesions.

Using this tool, they may be better able to decide on a course of treatment and proceed with greater confidence, according to Siemens.

While several elastography products are already out in the market today, these systems rely on manual compression to measure tissue strain.

“Depending on who performs the compression, the image may look very different,” said Dr. Dirk-Andre Clevert, section chief of the Interdisciplinary Ultrasound Center at Munich, University Hospital Grosshadern, to DOTmed News. The center has been using the Virtual Touch elastography system for five years.

Now, Siemens is only one of two manufacturers in the United States (the other being Hologic, Inc.) to offer an elastography system that uses acoustic radiation force impulse imaging to put stress on the tissue in place of manual compression.

While elastography’s sensitivity offered numerous advantages, there is big advantage to be gained from eschewing manual compression. Ultrasound’s major weakness as a modality is its user dependence, so automating this step ensures that the results are more reproducible from user to user.

One of the most obvious applications for this new technology is in breast imaging — a notoriously difficult part of the body to scan and interpret. After a mammography screening picks up a suspicious lesion, elastography systems such as Virtual Touch could be used to help clarify the nature of the lesion by measuring its tissue stiffness.

The technology may also help doctors quantify the lesion in a way that helps them positively identify cancers. “The same malignant lesion is larger in an elastogram than in a traditional 2-D image,” explained Jon Benson, director of clinical applications in product portfolio and strategy at Siemens Ultrasound, to DOTmed News.

In other words, preliminary findings show that a high elastography-to-2-D size ratio may indicate higher likelihood that the lesion is cancerous.

Training is probably the biggest barrier to wider adoption in the United States, though the automation helps reduce dependency on skill level, according to Siemens.

“It’s very easy to explain. After a couple of times using it, you feel very comfortable with this technique,” said Clevert. He explained that doctors familiar with ultrasound equipment should be able to use the system after about an hour of training, though he cautions doctors with little ultrasound experience will take longer to learn the system.

This may be a relevant point of difference for the U.S. market, since ultrasound still hasn’t made as much headway in the States compared with Europe — indeed, ultrasound proponents are still trying to push for more ultrasound training for doctors during medical school to get them more comfortable with the modality.

“It’s a new technology people will need to learn and understand, but I think that should be something we can overcome relatively quickly,” said Benson.



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