SOMATOM Definition Flash

DOTmed Industry Sector Report: CT

May 13, 2010

by Kathy Mahdoubi, Senior Correspondent

This report originally appeared in the April 2010 issue of DOTmed Business News

A few years of depressing sales doesn't seem to be holding the CT industry back. In 2009, the industry was valued at about $1 billion and sales were estimated to be down an estimated 10 to 15 percent industry-wide. Manufacturers are still selling their most advanced CT systems, but now more than ever, hospitals are gauging actual need and going for the technology that meets it succinctly, instead of reaching for the top-of-the-line CT every time.

Until the effects of the DRA hit the market in 2007, most imaging facilities were opening their wallets and spending big, but now many facilities are opting out of the bells and whistles in the name of what's affordable in the current climate.

GE Discovery CT750 HD

"The market is down overall in dollars, but what we're seeing is people who previously would have bought a 64-slice CT are downgrading to a 32 or a 16," says Robb Young, senior manager for Toshiba's CT Systems division. "People are still buying CT, maybe a little less than they would have in the past, but it's clinically appropriate. One thing about CT is that it's such an essential modality for that initial assessment of a lot of issues, whether the issue is cancer, trauma or stroke. A lot of hospitals that have acute stroke, pediatric or ERs are looking at top-end systems, and then if they have a large radiology department they may buy one or multiple 64s, and if they're not doing a lot of advanced procedures such as cardiac they may be looking at a 32 or a 16."

CT from the inside

Dr. Stuart Silverman is a professor of radiology at Harvard Medical School and director of CT scanning at Brigham and Women's Hospital in Boston. DOTmed spoke with Dr. Silverman about how CT technology and procedures have changed since the early 1990s.

Two major advances have happened - the first advance came with spiral computed tomography, which allowed CT to be acquired volumetrically in a single breath-hold. Spiral CT revolutionized the CT industry, but it wasn't the only major innovation in recent years. The next advance came with multi-detector CT, which not only allowed images to be obtained volumetrically, but at very high spatial resolutions that enable radiologists to detect minute structures without any respiratory artifacts. The latest systems feature technologies based on years of research and development, including CT scanners with dual X-ray sources that can scan at different energy levels for unique characterization of tissues.

"That's relatively new and a lot of research needs to be done to find out where dual energy or dual source CT plays in the overall care of patients," says Dr. Silverman. "There are many potential advantages, but dual energy CT has not yet gotten into the mainstream of clinical practice." The most benefit may be seen in cardiac and vascular imaging, but with innovation and newfound acuity come some new challenges.

"One of the major problems facing radiologists in the interpretation of images that have such high spatial resolution is finding very small mass-like lesions in many organs, including the lungs, the liver and the kidneys. Although some are clinically important, most are not. It challenges us to manage those findings in a way that is both medically appropriate and cost-effective," says Dr. Silverman.

iDose overcomes limitations
(image noise) of conventional FBP
(Filtered Back Projection) reconstruction.
(Image courtesy of Philips)

Dr. Silverman is currently involved in an effort by the American College of Radiology to develop policies and recommendations for these findings. Some of the lesions may be cancerous, but Dr. Silverman says most are benign and exploration would engender many more tests at a greater cost and with added psychological strain for the patient.

In addition to the new landscape of "pseudodisease" that becomes apparent at such high resolutions, there is the sheer breadth of data acquired. There can be thousands of images to interpret, and much of the interpretation being done is not based on volumetric images.

"The truth of the matter is that the analysis of lesions and how they appear are often based on planar images, not volumetric images," states Dr. Silverman. "Volumetric, 3D images using volume-rendering or maximum intensity projection - these are useful images for looking at structures and their relationships for surgical or interventional planning, but the actual analysis of the morphology of a particular lesion is still largely dependent on its appearance on planar images. The amount of time it takes to examine the dataset is quite long and challenging. The benefits outweigh the downside, in that the image quality and the ability to use these images to diagnose are phenomenal, and that is why the use of CT in clinical practice has skyrocketed."

CT's newest wares

The most advanced systems are going for about $2 million and many 64-slice systems are selling for under $1 million now.

Philips Brilliance iCT

Representative of most major CT manufacturers, Toshiba offers a range of scanners, including a 16, 32, 64 and 160-slice system, as well as the staggering 320-slice CT system dubbed the Aquilion One, which was released just shy of reimbursement cuts in November, 2007. That's not to say that no one is buying. The pull of the Aquilion One is that it can reportedly image an entire organ in a single gantry rotation.

"Our 320 can actually assess stroke in less than 5 minutes," says Young, "with about half to a quarter of the dose of a 64 CT scan."

Philips Healthcare has expanded their Brilliance CT line last year with two new configurations for cost-conscious facilities - the Brilliance iCT SP and the MX 16-slice system. The company is paying attention to increased demand for lower level slice systems.

"Product mix varies by clinical need and/or focus and geography," notes Jason Plante, director of global CT field marketing for Philips Healthcare. "For example, in North America, CT sales (by revenue) are pretty evenly split among 16-slice, 32-slice and 64-slice systems. In some emerging markets, on the other hand, there is a much greater proportion of 16-slice and below sales."

Market-share leader GE Healthcare has come out with two major developments for the company's Discovery CT750 HD, a 64-slice system released in October 2008. At the most recent RSNA, GE introduced Gemstone Spectral Imaging (GSI), a dual-energy application employing a garnet-based scintillator. The new application allows a multitude of user-selectable energy levels and GE says the new detector is capable of acquiring images 100 times faster with heart imaging registering in as much as 47 percent greater detail.

"When we launched the HD the main thing was having a brand new detector material," says Nilesh Shah, global marketing leader for GE Healthcare CT Systems. "It was about 10 years in the making."

GE also introduced ASIR, which stands for Adaptive Statistical Iterative Reconstruction, a new post-processing technique that has shown to dramatically reduce image noise and lower dose.

The other major manufacturer to come out with dual-energy CT technology is Siemens Healthcare with their SOMATOM Definition Flash Dual Source CT Scanner.

"The Definition Flash is our second generation dual-source CT technology launched at RSNA 2008," says Murat Gungor, senior director of product marketing for CT at Siemens. "It acquires information in a much more rapid manner then any single-source CT."

Gungor describes the use of dual energies as a way to acquire totally different information about the patient and particular tissues, and although there are two separate sources, there is no additional radiation dose. With this technology, you can target specific areas of the anatomy and remove bones from the images without any post-processing.

"In very simple terms, when you are scanning the chest of a patient on a single-source CT technology, no matter the slice, you can complete the entire chest examination in a about five seconds," says Gungor. "With this technology, the chest examination can be completed in about two-thirds of a second. This obviously eliminates the need for breath holding, which is a major milestone."

Siemens has also introduced proprietary reconstruction software called IRIS, which stands for Iterative Reconstruction in Image Space. This software increases sharpness and also reduces noise while requiring a lower dose of radiation.

From the remarketer's perspective

One branch of the industry privy to the competitive nature of today's market is the independent sales and service organizations that deal largely in CT and other major imaging systems.

The new year has brought good business to C&G Technologies, a refurbished systems sales, service and parts company based in Jeffersonville, Ind. C&G specializes in CT systems. President Greg Kramer says CT-related sales have been picking up steadily.

Fully refurbished GE LightSpeed 16
slice CT staged at C&G Technologies.

"All three of our revenue streams - refurbished systems, parts and service - are up," says Kramer. "In particular, system sales are up 30 percent over this time last year. We are seeing more and more facilities that never would have considered used equipment before, looking for used equipment now."

Rick Stockton, president of Nationwide Imaging Services out of Brick, N.J., says 16-slice systems are in highest demand right now, but there is also interest in 64-slice scanners.

"More customers are buying lower-cost systems or the 16-slice scanners," remarks Stockton.

Kramer agrees that 64-slice scanners are still moving, but not as quickly as 16-slice CT systems. "We have sold some 64, but the sales cycle is very long," he says. "Any hospital approval process is getting more complicated and difficult to get through."

GE QXI CT gantry cover in
the painting stage of the
refurbishing process at
Nationwide Imaging.

Competition in the used market seems also to be picking up. "There have been a couple new players in the market and people are getting more aggressive, but the steady players are going to continue to dominate," says Kramer.

More focus on hospitals

Since the 2007 Deficit Reduction Act went into effect in 2007, the nation's outpatient imaging centers have seen dramatic reductions in CT reimbursement. Manufacturers like Toshiba previously saw 30 percent of their sales coming from outpatient imaging, whereas now that number has dwindled down to about 10 percent and the majority of the market is centered on hospitals. For some, this means a significantly different rhythm of doing business.

"We do still sell some outpatient imaging, but it's not as major of a focus," says Young. "That actually changes our sales cycle. Outpatient imaging can typically be a six-month sales cycle, because it's very easy to get equipment into a little mini-mall or something like that, versus a hospital can be about 12 to 18 months. You just have to think differently and plan differently. We're talking to people now who probably won't get systems in until the end of 2010, but in a way it's better because you can plan out the right CT for them, which is better for health care."

Lowering the dose

Never before has radiation dose weighed so heavily on the design and engineering of new CT systems, but this has long been a concern for radiologists.

"We as radiologists are always concerned about using radiation with medical testing and we want to make sure it is used appropriately for patients, because we don't have a known threshold of radiation below which we know there's no increased risk of cancer," says Dr. Silverman. "There's a lot of work going into radiation dose. The best way to reduce radiation is with the clinical question of whether or not to do the scan at all. That's always in the forefront of the radiologist's mind."

But if the scan must be done, today's scanners and their software can alter dose parameters, and many systems offer post-processing and filters that require less radiation.

"There are several different ways to lower dose," says Young. "One way is to actually lower the amount of radiation coming out of the system. We can do that with what's called tube modulation...another approach is making the image better by reducing noise in the image."

Most new models feature sophisticated software like GE's ASIR, Siemens' IRIS and Philips' iDose software, and Toshiba has something called Quantum Denoising Software (QDS), that allow radiologists to significantly reduce radiation dose - up to about 80 percent reduction in some cases. The speed of a given scan can play a major role.

"For a coronary CT examination on any single-source CT scanner - and it doesn't matter if it's a 320, 256 or 64-slice - scanning the heart itself takes about 3 to 20 seconds, depending on the scanner," says Gungor. "To give you just a quick idea of background radiation, if you go outside and stand and look around, you'll be collecting about 3 mSv of dose per year, depending on where you live. That's the average background radiation. So a coronary CT examination on a conventional single source CT technology is about 5 to 20 mSv. With the Flash technology, the heart can be scanned in a quarter of a second. You need only 250 milliseconds to scan the heart and thus your dose level drops dramatically to about .8 or .9 mSv, depending on the patient."

It's not only about lowering radiation dose, but the amount of contrast media necessary to perform a given scan. Certain contrast media have been associated with kidney complications. Most of the major manufacturers have designed software and applications geared toward lowering contrast media dose.

Even in the refurbished market, independent sales and service companies are starting to provide radiation-dose reduction systems for refurbished scanners.

"There has been a lot of concern over dosage which in turn causes people to be concerned about the quality of what they buy," says Kramer. C&G has been offering an FDA-approved dose-reduction software that reduces radiation dose up to 50 percent using a workstation that applies specialized algorithms and image filtering to lower the dose. The company also offers extended warranties on X-ray tubes, but ironically these options haven't been flying off the shelf because of the added expense.

"Nobody wants to pay for it," says Kramer. "You would think with all the recent activity going on, with lawsuits and people getting exposed [to harmful levels radiation from CT systems], you would think more people would be interested, but they aren't buying."

As the trend toward dose-lowering continues, this may turn around in the used market. Kramer is banking on it with the addition of a brand new dose-lowering system coming out in the near future.

Growth in procedures

Growth in sales may have been a little dreary for most of 2009, but the number of procedures is still on the increase.

"CT procedures in North America continue to grow at about 10% per year," remarks Plante. "This growth comes from all clinical protocols, but especially CT angiography (CTA) exams including cardiac CTA."

In addition to cardiac imaging, other areas of growth include neuro and pediatric imaging. CT is also the most commonly used tool for interventional procedures like biopsies, drainages and tumor ablations.

"Right now at Toshiba we are researching a lot of different things," says Young. "We're researching functional and perfusion imaging - we already have it in the brain, but we're looking at doing it in the heart, which could compete with or help augment nuclear or PET scanning as well as body perfusion to look at tumor imaging. What we're seeing is a need for more automation and tools for dose reduction."

Additional applications for CT should develop as CT becomes more like MRI and nuclear imaging by being able to distinguish important characteristics of tissues.

"One of the applications that hopefully soon will become more mainstream is CT colonography," says Dr. Silverman. "In this procedure, the colon is inflated with gas and the CT scan is obtained in both the supine and prone position and the walls of the colon are examined for polyps or cancers. This tool gives us the opportunity to screen many more patients for colon cancer than can be screened using conventional optical colonoscopy."

What about the most diminutive and vulnerable of patients? Today's scanners and dose-lowering software have made it so that children can be scanned in one second, which all but eliminates the need for sedation, an unsavory affair for both doctors and patients.

"CT continues to play an important role in pediatric imaging, especially in acute situations when fast results are essential," says Plante. "As with all requests for imaging, but especially with pediatrics, careful consideration must be given to the applicability of CT. Other techniques that use no ionizing radiation, such as ultrasound or MR, may in some cases be preferred."

Nano CT?

In the far reaches of research and development is talk of a brand new CT technology that would implement a multitude of "nano" X-ray sources, instead of the conventional one or two X-ray tubes. Siemens is known to be involved in this research, and other manufacturers seem interested, as well, but no one is really talking just yet.

"It's on our radar; it's an interesting topic and our researchers are focused on it heavily," says Gungor.

A new year and a lift for CT
Despite the ongoing effects of the DRA and what's to come regarding the dreaded utilization rate, most of those surveyed have forecast relief for the CT industry in 2010.

"Both CT and PET/CT markets in North America enjoyed significant upticks in Q4 2009 providing optimism that further improvements may be expected in 2010," says Young.
"A lot of hospitals had to refocus money from capital equipment to their pension plans and a lot of purchases were put on hold. They weren't canceled; they were just delayed. Now those delays are lifting up."

This is good news for manufacturers and excellent news for hospitals, which could finally start bringing in new technology after an era of capital freeze. Whether it's a 16-slice, a 64-slice, a 320-row or dual-energy system, CT appears to be slicing through what could turn out to be the most troublesome period for the industry since the turn of the century.