Medical Device Daily

PARIS — A novel diagnostic tool for detecting and characterizing tumors that promises to revolutionize screenings for breast and prostate cancers has been cleared for commercialization in the U.S.

SuperSonic Imagine (Aix-En-Provence, France) reported it received 510(k) approval from the FDA for Aixplorer, an ultrasound system that combines a high-end B-mode ultrasound with an innovative shear wave modality capable of measuring tissue stiffness or elasticity.

Shear wave is a sophisticated enhancement for the tried-and-true medical exam technique called palpitation where the doctor presses a patient's skin to feel for stiffness of a liver or a breast lump.

This first-line exam is based on the good sense that supple tissue is healthy and stiff tissue is not.

Shear wave technology takes the palpitation test to a new level by providing quantifiable data to characterize the tissue, which combined with high quality B-mode images, enables radiologists to diagnose the nature of a tumor.

Current screenings for breast cancer, for example, rely on X-ray exams followed by biopsies of any suspect tissue to characterize and diagnose tumors.

Shear wave exams potentially could eliminate several steps and costly imaging procedures by providing a one-step detection and tissue characterization exam, enabling physicians to more precisely target lesions requiring a biopsy.

Such exams could reduce the number of biopsies, another potential cost savings, and also provide more immediate results for patients who today must wait weeks to hear whether a suspected tumor is malignant or benign.

While several companies provide ultrasound elasticity exams using a compression method, where the scanner operator presses down on tissue to create a sonic wave to measure tissue stiffness, Aixplorer is the only FDA-approved device that produces a pulse with its transducers to create the same effect (Medical Device Daily, March 13, 2009).

Jacques Souquet, the founder of SuperSonic, dismisses the operator compression technique as highly dependent on the skill level and experience of a given operator, and therefore not clinically reliable as results are not reproducible, even by the same operator with a second exam.

Compression ultrasound provides "only a global assessment of deformation where shear wave pulse provides a local assessment of specific lesion stiffness," he said.

A demonstration of the Aixplorer platform featuring the proprietary ShearWave, which renders tissue images 200 times faster than conventional ultrasound and produces a color-coded map of breast lesions, was first given at the Radiological Society of North America meeting in Chicago in December, 2008.

"Since we introduced Aixplorer there has been a great deal of anticipation for its FDA approval," said Souquet, who adds that "elastography is the next level and the future of ultrasound."

The market potential for Aixplorer in the U.S. is significant according to Edward McClenny, Supersonic's General Manager for the Americas.

"We've talked to hundreds of doctors and sonographers and it is the combination of a spectacular image quality and the potential for ShearWave elastography that is driving the excitement," he said.

The company received its CE mark in early 2009 and began shipping Aixplorer units in April.

"Our sales funnel has exceeded our expectations for the first three months of this year and we are building up the capacity to meet this kind of demand," he told Medical Device Daily.

SuperSonic is currently completing a study of breast exams using shear wave across 15 medical centers, including seven in the U.S. and 10 in Europe.

The endpoint for the study is to demonstrate the specificity of the shear wave exam in detecting tumors.

"In the United States there are two million breast biopsies performed each year, yet 80% of these biopsies return negative results," said Souquet.

"That is a heavy cost to the healthcare system so if we are able to clinically demonstrate that we can reduce the number of biopsies required, that could represent significant savings," he said.

Physicians at Hammersmith-Charring Cross Hospital (London), who are participating in the Supersonic study, estimate the reduction in biopsies could be as high as 50%, he said, while partner hospitals in the U.S. are more conservative saying it could be reduced by 30% to 40%.

"If we demonstrate the effectiveness for breast examinations we plan to move on to the prostate and the liver," Souquet said.

Earlier this year, the French innovation funding agency OSEO invested €8.5 million ($11 million) in a collaboration between Supersonic and Paris-based Theraclion to develop a novel treatment for hyperparathyroidism with real-time imaging of the therapy.

The TUCE project (Traitement Ultrasonore Controllé Elastrographie) combines Theraclion's Thyrus stereotactic targeting for HIFU (high-intensity focused ultrasound) with the Aixplorer from Supersonic measuring tissue elasticity (MDD, Feb. 12, 2009).