PARIS — The clinical adoption of elastography for ultrasound examinations is hard to determine. But manufacturers are rapidly adapting the technology to their platforms intensifying the competition for this "must-have" product feature.
Until this year only the pioneer in the technology, Hitachi Medical (Tokyo), and another Japanese powerhouse in medical imaging, Toshiba Medical Systems (Otawara, Japan) offered the ability to determine the elasticity of tissue using ultrasound.
Yet at the Journées Françaises de Radiologie 2009 held here last week at least six companies were presenting CE-approved platforms for the diagnosis with four different technological approaches and five areas of clinical application opening a vast field for competition.
"Everyone here has elastography, including some who only have a prototype version." sighed Heinz Schreiber, head of Ultrasound for Hitachi Medical Systems Europe (Zug, Switzerland), adding "They are using our clinical evidence to prove that their device is clinically relevant," he told Medical Device Daily.
"In a few years elastography will be a standard feature, call it the E-mode, for ultrasound," he said. "It will be like air conditioning in a car, difficult to find a car without it."
Hitachi continues to hold an advantage having expanded elastography to all its scanners, he said, where this feature is only available on the high end ultrasound platforms from competitors.
The rush-to-market ahead of clinical adoption is based on the potential that ultrasound will become an easy-to-use examination for identifying lesions and tissue damage across a broad number of medical practices.
Elastography simply determines if tissue is smooth and supple or whether it is rigid. Stiff tissue is neither normal nor healthy.
It is the oldest of all techniques for a medical exam, called palpitation, whether it is finger-poking by a general physician to see how stiff a patient's liver may be, or a woman feeling a lump in her breast.
Ultrasound palpitation depends on picking up a disturbance in the echo signals returning to the transducer, like measuring the ripples in a pond when a pebble has broken the surface.
No new hardware is required, just a new set of algorithms loaded into the signal processor to pick out the relevant data and calculate what it means.
The fact that elastography is a software add-on and does not require the purchase of additional hardware explains why so many manufacturers have been able to rush products to market.
The first area of application for competitors is the massive market for mammography where elastography can identify nodules and during the same examination improve the diagnosis as to whether the nodule is merits a more invasive biopsy.
The possibility that elastography can reduce the number of breast biopsies ordered each year, which return negative results in 80% of cases, would represent substantial cost savings for health systems, not to mention the tremendous psychological benefit for women who are asked to wait weeks and even months to learn the results.
Philips delivers elastography on IU22
Philips was the newest competitor to enter the competition, introducing at JFR 2009 elastography on its IU22 scanner platform.
The product introduction delivers on the promise of Radjen Ganpat, sales development manager for Ultrasound with Philips Healthcare EMEA (Böblingen, Germany), who said at the European Congress of Radiology (ECR) in Vienna in March, "we will have elastography on the IU22 by the end of 2009" (Medical Device Daily, March 13, 2009).
Joana Crochet, head of Philips Ultrasound for France, was demonstrating the capability at JFR 2009 and explained elastography on the IU22 introduces a different technology for acquiring the image.
"Right now there is the compression technique with Hitachi, a push-pulse used by Siemens (Erlangen, Germany) and the ShearWave from SuperSonic (Paris)," she said.
The Philips IU22 elastography, which does not yet have a brand name, relies on a sensitivity sufficient to pick up the palpitations in tissue caused by natural rhythms such as pulsations of arteries or respiration.
The two targeted applications for Philips are the thyroid, which has sufficient arterial disturbances to produce an elastographic rendering, and the breast, thanks to natural breathing movements.
Crochet said the Philips advantage will be the combination of the color-coded readings of tissue stiffness with the IU22 capabilities for both 2-D and 3-D viewing, enabling a much more complete picture for doctors to make their diagnosis.
"For us elastography is not a revolution, it is more a progression for the IU22, adding a useful feature to our ultrasound line," she said.
Supersonic study goes head-to-head with biopsies
Based in Aix-en-Provence, Supersonic Imagine was working its home court advantage with its second showing of the Aixplorer at JFR.
Elastography is not an add-on feature for the Aixplorer, which won FDA approval in August and is now being sold in 15 countries. (MDD, Aug. 27, 2009)
Instead elastography is the leading edge of the Supersonic technology with Aixplorer built from scratch using a hyper-fast novel video gaming motherboard processor combined with a proprietary ShearWave technology that sends a cone-shaped beam into targeted tissue.
The result is a different data set than other ultrasound signals and novel analytics that create the potential to not only say if a breast nodule is suspicious, but to clinically quantify it according to American College of Radiology BI-RAD score (Breast Imaging-Reporting and Data System) as to whether a nodule is considered insignificant with a score of 1 to malignant with a score of 4.
As a result the company's ambition is bolder than ultrasound manufacturers offering elastography as an adjunct examination.
Supersonic believes Aixplorer is a disruptive alternative to traditional biopsies in potentially up to 50% of all cases.
In September the company reported preliminary results from 222 patients participating in an international multi-center trial for which the end point is a head-to-head comparison of Aixplorer diagnostics of breast nodules with histological exams.
Seven of the 17 sites are in the U.S. and the final study will be report on findings from 1,000 patients with more than 22,000 images evaluated for eight parameters.
Company founder Jacques Souquet reported sensitivity and specificity are "extremely high" heading upwards from 93% on the first patients, and that he was confident of approaching 100% accuracy with BI-RAD scores.
"We now want to get to 2,000 patients to power these conclusions," he told MDD.
Not only is Supersonic not borrowing Hitachi clinical studies to make the case for Aixplorer, but the company hijacked one of Hitachi's lead investigators Anne Tardivon, a radiologist at the Department of Radiology of the Institut Curie (Paris).
Tardivon, who presented findings for Hitachi at ECR on "Elastography emerges as valuable adjunct technique to B-mode imaging for differentiation of masses," said that with Supersonic ShearWave, "we work in real-time with quantificative results and save on biopsies."
"If you take 10 women off the street under the age of 50, they will all have these nodules," she said. "As the images from ShearWave demonstrate there is a clear identification of the nature of the nodule, and so we eliminate a biopsy."
She said MRI is highly sensitive for breast examinations, "but as soon as we spot something with MRI, we order up an echo anyway. So why not go directly to a quantifiable result with the first examination?"