Meta Imaging Solutions, LLC, based in Columbia, MO, announced a 510K pre-marketing approval by the FDA for the patent-pending Chrysalis Breast Displacement System. The Chrysalis is an innovative means of decreasing breast radiation dose while doing CT coronary angiography and CT of the abdomen. It was introduced at the AHRA convention held in Denver in July.

Charles Swaney, a practicing radiologist who developed the device, spoke with DOTmed News to talk about what makes the product special.

"The system is unique in that I know of no other devices that are designed to displace tissue for CT scanning," Swaney said. "It is useful in that, particularly with CTCA, decreased tissue means improved signal for CT images. In CTCA, the breasts are in the plane of imaging, but do not contribute to the data we are evaluating. In patients with large breasts, there can be significantly decreased image quality. By displacing the breasts manually and securing the breasts out of the imaging plane, you can both improve image quality and decrease the radiation dose to the breasts."

In contrast to other dose-reduction methods, the breasts are physically displaced out of the imaging plane and secured with the Chrysalis device. A randomized trial showed median dose reductions of 88% in the peri-areolar region and 95% in the upper quadrants while at the same time showing improved image quality in patients with large breasts.

"It is used to decrease radiation dose and improve image quality in CTCA and CT of the abdomen," Swaney said. "Any other application where a decrease in tissue would improve image quality by increasing the signal would be an additional application. These have not been directly tested, but would include nuclear medicine images of the heart and MRI of the heart."

With heightened concern about radiation exposure, this can be an effective way to reduce dose while at the same time improve image quality because there is less tissue in the scan plane.

The device is constructed of soft, padded vinyl to encircle the patient. There are four components that may be inter-connected to fit to all patient sizes. Optional external shielding can be accurately placed out of the imagine plane by means of fiducial markers on the Chrysalis and secured to the device by Velcro.

For further information on the Crysalis Breast Displacement System visit www.metaimagingsolutions.com.

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