GE Vscan™

Ultrasound is making noise

June 10, 2010

by Olga Deshchenko, DOTmed News Reporter

Ultrasound technology seems to be having its day. Today, the popular imaging modality can be found throughout the hospital as an important tool for a number of procedures. At a time when hospitals are looking to curb spending, new applications for ultrasound are being investigated as an alternative to pricier modalities. As a noninvasive, non-ionizing and cost-effective technology with a wide range of possible uses, ultrasound is here to stay and thrive.

The ultrasound market is projected to grow to more than $5.3 billion by 2016, according to a report by Marketstrat, Inc., a California-based company specializing in medical research. Key topics at the recent annual convention for the American Institute of Ultrasound in Medicine (AIUM) included miniaturization, improvement in image quality, fusion of modalities, 3D capabilities and elastography. Despite declining reimbursement rates that pose a challenge for the industry, manufacturers and users agree that ultrasound will remain a viable technology.

"Ultrasound continues to be much cheaper than MRI or CT and the results are available immediately," says Dr. Jacques Abramowicz, AIUM Annual Convention committee chair.

Several new units on the market today are designed with an emphasis on portability, higher image quality, ease of use and a diversity of diagnostic applications. Some companies are also marketing their products to appeal to nontraditional ultrasound users.

Does That Come in Miniature?
For ultrasound, size matters. The trend in miniaturization continues to grow and portability is also a key draw that is helping to move units as well.

GE Venue 40

"It seems as if portable systems and smaller stand alone systems are in demand," says Bill Cowan, vice president of Liberty Diagnostic Services, a pre-owned ultrasound sales and service company. "The image quality of the portable systems has caught up to the full size systems."

GE Healthcare recently introduced the Venue 40, a miniaturized ultrasound system with touch-screen technology. The unit has five applications: vascular access, anesthesia, interventional, musculoskeletal and point-of-care. The point-of-care application can be used in the ER to speed diagnosis or in a department like the ICU in the course of treating a patient.

"There are all these procedures that are evolving...where you can use ultrasound to do a better job, to see what you're doing or to aid in a quick diagnostic," says Jeff Peiffer, global marketing and product development for point-of-care markets at GE Healthcare. "This is what's occurring outside the traditional market."

The Venue 40's touch-screen technology eliminates all the buttons, knobs and the keyboard. It has a continuous flat surface facilitating cleaning to maintain sterile hospital environments. The unit's size and simple interface likely prove less intimidating to those new to ultrasound use.

"The thing that's unique about these users is that they're not sonographers, they're primarily physicians. The Venue 40 has a lot of inherently intuitive characteristics, it's meant to be really easy to use," says Peiffer. "If you walked up to a Venue 40, your first impression would be, 'this doesn't look like an ultrasound machine.' It has a very friendly design."

Philips CX50 Portable
Ultrasound System

The cost of a Venue 40 can range between $25,000 and $35,000, depending on the configuration, additional features and transducers.

GE Healthcare also recently introduced the Vscan, a new pocket-sized visualization tool that uses ultrasound technology for imaging, measurement and analysis in the abdominal, cardiac, urological, fetal/OB applications and fluid detection. The product is meant to enhance the quality, ease and speed of a physical exam.

"Some of the product features that we're really excited about are the portability, the size and the weight of the unit," says Al Lojewski, global general manager of cardiovascular ultrasound at GE Healthcare. "The whole unit weighs less than a pound." Its images are stored on a micro SD card and can be viewed using the product's software. The Vscan is marketed toward nontraditional users but it is also not a typical ultrasound unit.

"[What] we've done with Vscan that's different is that we did not think of this as a miniature ultrasound device," says Lojewski. "It's a device specifically designed to enhance the physical exam and the immediacy of the answers that physicians want to give to their patients," he says.

The Vscan's global price is $7,900.

Philips Healthcare is also continuing to invest in ultrasound and portability of the systems. The CX50 CompactXtreme Ultrasound System is equipped with SmartExam system-guided protocols and can be hand carried between departments.

"The portability of this system really fits nicely with a number of our customers," says Kevin Appareti, senior marketing manager of ultrasound at Philips Healthcare. "My experience is mostly in cardiology and I can tell you that an increasing number of exams are being done portably," he says.

According to "Ultrasound: Waves of Change," a new report from KLAS, a research firm specializing in health care performance of vendors, mobility of equipment is a key factor for providers when it comes to choosing an ultrasound unit.

"One of the reasons that it's so incredibly important is because it's being used by so many departments in a hospital and they can't have dedicated machines for each department or each room," says Emily Crane, KLAS research director and author of the report. "For the most part, [units] are being moved around a lot."

KLAS found that "no vendor has delivered the ultimate solution in ultrasound - a highly mobile unit packaged with deep image penetration and picture clarity." The firm interviewed more than 200 health care providers for the report.

"As you get smaller to be more mobile, you leave some of the image penetration," says Kirk Ising, KLAS research director and author of the report. "There's some new technology, but there are some issues that are being worked out that providers are dealing with."

Philips iU22
Ultrasound System

Elastography Stretches Ultrasound Possibilities
Elastography, a technique that employs tissue elasticity to detect malignant masses, is one of the emerging trends in ultrasound technology. Developed in the U.S. in the early 1990s, commercialized elastography made a splash at the European Congress of Radiology earlier this year.

"Elastography is a technique that we've been working on for many years. We think it's robust, easy to use and sensitive," says Ron Leichner, director of marketing of ultrasound and radiology at Philips Healthcare. "It has great results from clinical trials and I think it offers a key piece of imaging information with breast imaging."

Philips introduced elastography on its iU22 unit with the Vision 2010 upgrade, an addition to its breast imaging platform. The company received FDA clearance on its elastography solution a little more than a month ago.

"Eventually, I see elastography as a button-like color flow on the system. It's another piece of information with a really interesting technology that we think is very valuable," says Leichner. "More elastography features are going to be on the iU22 for things like the liver, the thyroid and the prostate."

GE Healthcare first announced the elastography feature on its LOGIQ E9 unit in March at the AIUM Annual Convention. It uses a high frequency E-series transducer with a simple compression technique.

"Physicians have traditionally examined differences in tissue by hand palpation during physical exams," says a spokesperson for GE Healthcare. "The LOGIQ E9's elastography capability helps give doctors a digital interpretation of the physical exam that can be easier to reproduce in follow-up examinations by either the original physician or other clinicians."

SuperSonic Imagine, a French company, is taking elastography to another level. Its ShearWave Elastography technology measures the velocity of shear waves to produce a quantitative, color-coded representation of tissue elasticity.

"Conventional elastography looks at tissue deformation. What we do is find a special wave in the tissue called a shear wave, which speeds up propagation that's directly dependent on tissue elasticity or tissue thickness," says Jacques Souquet, the company's founder and CEO. "We measure the speed of what each shear wave propagates to extract the data."

A disadvantage of conventional or static elastography is that the success of its application is dependent on the user's training and experience. ShearWave Elastography is user-skill independent.

"The user is not required to push on the organ with the probe, which is what conventional elastography requires to create the deformation in the tissue. Here, everything is being done by sending a special train of ultrasound pulses on the transducer," says Souquet. "We extract the number, it is quantitative and it is in real-time."

At an ECR Congress symposium, SuperSonic Imagine presented the preliminary results of the largest breast trial ever undertaken by an ultrasound company. The goal of the study was to assess the advantages of adding elasticity imaging to gray scale ultrasound for lesion classification.

"We had 17 sites, seven of them were in the U.S. and they all followed the same protocol. The results demonstrate that with our elastography method, we can significantly improve the specificity of the diagnostics, meaning that we are much better at saying which lesions are malignant and which are benign," says Souquet.

The SuperSonic Imagine Aixplorer ultrasound system received FDA clearance in 2009. The unit's quantitative assessment capability is still pending approval in the U.S.

Currently, the technique is used for the detection of early breast cancer, liver fibrosis and lesions of the thyroid. In the future, the company plans to use the technology in cardiovascular, prostate and musculoskeletal applications.

Many OEMs are enhancing their units by adding on an elastography feature and working on ways to improve the technique.

Ripples in Women's Health
Although ultrasound moved beyond prenatal care a long time ago, it continues to impact women's health. In some cases, the modality crossed over into therapeutic procedures.

3-D Ultrasound of a
fetal face at 35 weeks.

"I think this whole concept of having ultrasound being integrated into therapy is a very strong trend across most of the applications in medicine right now," says Appareti of Philips Healthcare. "It's pulling ultrasound from a noninvasive diagnostic tool to now a tool that not only helps select the patient to go to therapy but actually helps in the therapeutic procedure."

Resonant Medical Inc., a Canadian company, develops and manufactures 3D ultrasound image-guided adaptive radiotherapy products. Its Clarity Breast System operates in over a 100 facilities throughout North American and Europe.

"The Clarity Breast System marks the first application of 3D ultrasound technology to improve treatment planning and Image-Guided Radiation Therapy in breast cancer," says Tony Falco, the company's CEO.

The machine enables therapists to image the exact location of the tumor cavity on a regular basis, which may shift due to healing, scarring or physical movement. It targets the area of therapy delivery, without any additional radiation from the system.

"The radiation oncologist fuses 3D ultrasound images to CT images, to make a better plan from the onset than could have been achieved using the CT images alone," says Falco. "Similarly, before each treatment, therapists compare the initial 3D ultrasound with a daily ultrasound to get an actual visual image and location of the tumor cavity and correct for any motion or change in shape of the cavity. This ensures delivery of radiation to the targeted area, and ensures sparing of the healthy tissue surrounding it," he says.

The system can cost anywhere between $300,000 and $500,000, depending on the configuration.

A scientific presentation at the recent National Consortium of Breast Centers (NCBC) Conference featured the latest research on Warm Bath Ultrasound (WBU) technology from TechniScan Medical Systems Inc., an Ohio-based developer of automated ultrasound imaging systems.

With the use of the machine developed by the company, WBU technology captures 3D images of the breast as the woman lies on the table with the breast of interest submerged in a warm tank of water.

"Whole breast ultrasound in use today uses a reflection ultrasound to develop the picture. What TechniScan is doing that is revolutionary is using a transmission ultrasound that uses speed of sound and sound attenuation as it travels through the breast," says Tracy Harden, director of marketing and communications for TechniScan. "The result is that we give three different quantitative pictures of the breast using speed of sound, reflection and attenuation. It's a true 3D image of the breast," she says.

WBU technology is currently in study throughout U.S. and European locations. The company has filed an application with the FDA for marketing clearance of the system.

Turning Up the Heat
High intensity focus ultrasound or HIFU is a forthcoming technology in the ultrasound industry. It uses high levels of heat to destroy unhealthy tissue.

FDA clinical trials are currently underway for the Sonablate 500, an image-guided acoustic ablation device for prostate disease therapy. The product is manufactured by US HIFU, a North Carolina-based health care company, focused on treating primary and recurrent prostate cancer.

The Sonablate 500 is currently undergoing trials at the NYU Cancer Institute among other sites. The study started last summer and will enroll 20 participants before its conclusion.

Philips iU22 Ultrasound
System with Breast
Elastography

"The machine works by concentrating several ultrasound beams on a single target. In our case, the target is a prostate gland," says Dr. William Huang, assistant professor of urologic oncology at the NYU School of Medicine. "A transrectal probe is used to visualize the prostate cancer but also treat the gland. The single focus of the ultrasound beams produce tremendous heat at the target area while leaving healthy nearby tissue untouched," he says.

The device is already being used in several countries outside the U.S. This particular trial will enroll 200 participants nationwide before its closure. Dr. Huang is optimistic about HIFU's potential.

"At this point, it is used for patients who have failed previous prostate cancer treatment utilizing external beam radiation. In the future, this can be used as a primary treatment modality, as well as treatment for other organs," he says.

Looking Ahead
Ultrasound's versatility, size and cost-effectiveness will keep the ultrasound market strong.

"Ultrasound systems are being used in a variety of places and for purposes that were not common in the past," says Cowan of Liberty Diagnostic Services. "Years ago, it was rare to see an ultrasound in the ED, now it is not uncommon to see a major hospital with more than one in the ED."

The ubiquity of the technology kept the resale and service sectors strong. For the most part, sales were steady or up in the used market during the last year. Many companies also saw an increase in international sales. MedCorp., one of the largest distributors of new and reconditioned ultrasound equipment, does business in countries all over Europe. Mark Asmer, the company's director of sales, believes that ultrasound will continue to grow, despite reimbursement issues.

"There have been some cuts in reimbursement that physicians have been concerned about, but ultrasound is still the most cost-effective modality for screening a lot of abnormalities and for diagnosing different indicators. I think in the long run, it's going to grow and be more readily adopted," says Asmer.

Others predict that some of the new technologies will become more prevalent in the resale market.

Sonablate 500

"More and more equipment is capable of 3D and 4D and everyone seems to want a smaller portable system," says Derrell McCrary, president of Choice Medical Systems Inc., a company that specializes in used ultrasound equipment sales. "Portable sales will be stronger in the marketplace than the console models," he says.

As a modality living in both diagnostic and therapeutic worlds, it is safe to say that ultrasound will remain an essential part of patient care.

"Ultrasound is a very accessible and portable technology. It's cost effective and its diagnostic quality continues to improve," says Asmer. "It's going to continue to be a primary diagnostic tool and it's going to continue to grow."