It wasn’t too long ago that ultrasound was a roiling sea of innovation and new product releases, spurred by a rivalry among Diasonics, ATL, Hewlett-Packard (Agilent Technologies), and Acuson. Since these companies’ acquisition by GE, Philips, and Siemens, the waters have calmed. Supersonic Imagine plans to begin making some waves -- and soon.
It wasn't too long ago that ultrasound was a roiling sea of innovation and new product releases, spurred by a rivalry among Diasonics, ATL, Hewlett-Packard (Agilent Technologies), and Acuson. Since these companies' acquisition by GE, Philips, and Siemens, the waters have calmed. Supersonic Imagine plans to begin making some waves -- and soon.
Coming off its first public appearance at RSNA 2008, the French start-up brought its Aixplorer ultrasound scanner to the ECR 2009 exhibit floor, demonstrating its own brand of elastography to uncover breast cancer. The system may be only days away from getting a CE Mark, opening the door to sales in the European Union, and weeks from a 510(k) clearance from the FDA, paving the way to begin marketing in the U.S. The company, according to its cofounder, chief scientific officer, and chief operating officer Claude Cohen-Bacrie, is ready to go.
"In Europe we already have people interested in buying the product, and we will be ready to deliver it as soon as we have the CE Mark," Cohen-Bacrie said.
Sales in the EU will be made through a mix of the company's own direct sales force and distributors, depending on the specific country. In the U.S., Supersonic Imagine will use "agents," distributors contracted to sell only Supersonic products.
Although the platform is robust enough to assess a range of tissues, Aixplorer -- named for the location of the company's headquarters, Aix-en-Provence -- is configured for just breast imaging. Malignant breast lesions, ductal carcinoma of the breast, and metastatic cancers of the lymph nodes are assessed without the kind of manual compression typically required by other forms of elastography. The tissues are color-coded onscreen according to their relative stiffness. The primary application of this technology is for diagnosis, but it also has prognostic value as tissue elasticity may change in response to therapy. (Hear audio clip below)
Color-coded elasto images provide functional information in the context of anatomical data much the way PET data do when fused with CT. The Aixplorer system includes a "blending" function that allows the operator to add the color-code elasto data at varying levels of transparency with a simple twist of a knob on the console.
"You can choose the level of elasto information to see on top of the gray-scale information," Cohen-Bacrie said.
Aixplorer uses the relative stiffness of tissue to differentiate healthy from diseased tissue. Its ShearWave Elastography technique produces consistent results regardless of the operator's skill, according to Cohen-Bacrie.
Competing systems depend on mechanical compression, typically the operator pressing the transducer against the patient. Supersonic, however, calculates elasticity electronically, leveraging shear waves created by the Aixplorer ultrasound beams. These waves, which travel through tissue at right angles from the beam, slow down in proportion to the stiffness of the tissue through which they pass.
Aixplorer records these changes in speed and turns the data into brilliantly colored maps of tissue elasticity from very soft (blue) to very stiff (red). A QBox tool quantifies elasticity with measurements and comparisons for specific regions of interest. A licensing agreement with the American College of Radiology brings the BI-RADS reporting tool into Aixplorer to simplify the reporting process.
Its independence from operator skill will translate into greater reproducibility across patients and users, according to Cohen-Bacrie. Its simplicity of operation, through a console with a minimal number of buttons and knobs, and ability to provide a qualitative and quantifiable basis for interpretation will add further to its appeal. Together these aspects of the technology hold the promise of translating the enormous but largely unrealized potential of elastography into clinical utility.