Philips Veradius3

DOTmed Industry Sector Report: C-Arms

May 10, 2010

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

It may have taken longer than some other imaging modalities-such as CT and MRI, but the digital revolution that has swept through those sectors seems to finally have infiltrated the C-arm branch. According to C-arm manufacturers, refurbishers and industry experts, the biggest news in C-Arms heading past 2010 concerns the first great leap forward in the digitalization of imaging OR.

"We're in a luxury spot where the biggest buzz in the industry is also the biggest buzz in the company currently," says Mark Manum, director of marketing for Philips' OR Channel. "For the last year, we have been actively involved in introducing to the market flat detector technology for mobile C-arms, which is something that has not really been available before."

What this means is that you can now get the same high level technology-the digital technology-you have on your cath lab available on your mobile C-arms. Flat panel detectors are direct digital imagers and have numerous advantages over an image intensifier. For one, the quality of the image obtained from an FPD is distortion-free and thereby more accurate to read. The FPDs are also much lighter and occupy less space as compared to an image intensifier and they can have a much larger active area for detecting the X-ray beam.

Philips started shipping the Veradius mobile C-arm system with flat detector at the end of 2009 and saw strong 4Q revenue, which has continued through early 2010.

"Business in 2010 is continuing the trend of the market being a lot stronger than it was last year," Manum says. "We have introduced the next generation of seeing forward in the changing OR landscape."

According to Philips, the compact mobile C-arm system makes it easier to work around the table during delicate cardiac, vascular and orthopedic surgery and provides the clarity for the most challenging minimally invasive procedures with more confidence. The super thin flat detector on the Veradius frees up valuable space in the OR, by providing more room to see team members and coordinate tasks, and also the space to see your patient.

Another manufacturer to offer mobile C-arms with digital flat panel detector technology is Ziehm Imaging Inc. Last year, the company released three models with the flat detectors-the Vision RFD (30 cm x 30 cm detector), the Vision FD (20 cm x 20 cm) detector and the Vision FD Vario 3D which has a 20x20 detector and 3D multiplanar image reconstruction capability with navigation system interface options.

The company released another important C-arm in February of this year-the Ziehm Solo.

"This is a compact, small footprint, one-piece design in which a 24" flat panel, split-screen display is attached to the C-arm chassis on an articulating arm, thereby eliminating the need for a separate monitor cart workstation," says Dan Edwards, VP of the Orlando, Fla.-based company.

Because of the well-publicized consent decree with the FDA that GE Healthcare and its OEC surgery business agreed to in 2007, they are unable to offer flat panel C-arm technology until 2011.

Elizabeth Usher, chief marketing officer for GE Healthcare Surgery, thinks there is a buzz over all this, but that it may not be as perfect as some believe.

"We do see a lot of interest in flat panel detectors. We think there is a general perception of a flat panel projector on a mobile C-arm that you get better image quality with that, but from our perspective, when you add a current flat panel detector on a mobile C-arm, you have to boost power and increase cooling, and our view is that today's flat panel detectors on a mobile C-arm, while they do produce nice images on small anatomy and less complex procedures, you don't see that translate across dense anatomy and more complex procedures."

Looking ahead a few years, Usher does believe that OEC will be looking at flat panel detectors in the future and will be able to bring that potential to all clinical and all patient types.

The main issue with the flat panel technology on C-arms today is that the cost is very high, and while it's a highly desired option, the economics don't make sense to everyone.

"As the price of flat panel technology goes down, those C-arms will become more mainstream," says Jeff Weiss, president of Atlantis Worldwide LLC. "Right now, flat panel detector C-arms are selling for $250,000 and high-end hospitals are going to buy that and we've seen that. Private imaging centers or smaller hospitals maybe will not spend that kind of money, but when it comes down to the mid-$100,000 range, we will see a whole turnover in technology."

But that switch is already happening according to some, who have witnessed prices starting to drop in the first quarter of 2010.

"There are a few companies that are streamlining their flat panel detectors and working out the kinks and reducing the costs for them to be practical enough to displace the tried-and-true image intensifier," says Leon Gugel, president of Long Island City, N.Y.-based Metropolis International.

Mini C-arms

According to Richard Keil, national sales manager for Hologic, Inc., the company still has the lion's share of the market for the mini C-arm.

"The business of the mini C-arm is healthy because there's a big demand and need for it," Keil says. "We are a price-sensitive market and we have to stay far enough below the cost of big C-arms to make us attractive to the extremity surgeons at surgery centers and hospitals."

Since the release of their top-selling digital mini C-arm a few years ago, Hologic has continued to update their software and make modifications to their equipment. For an extremity surgeon who wants to do a foot, hand or ankle surgery, the perfect solution has been this lower cost, lower dose, mini C-arm.

"We just came out with 3.0 software in the fall and have made some modifications. It's nothing major, but we have been trying to streamline it and make the C-arm a little deeper to accommodate all kinds of different hand tables that are in surgery departments," Keil says. "We made them a little more flexible, easier to handle. There was nothing dramatic done, but small incremental improvements in hardware and software have made it more user-friendly and easier for the doctors to use."

The advantages of a mini C-arm are that there is no need for an X-ray tech to operate them, and it offers a lower dose system overall. Physicians can also get immediate results.

"We have added in some nice programmable features for the physicians so they can customize their images on our system to give them the look they like," Keil says. "It gives them preferences they can program into the system."

Currently, the mini C-arms aren't utilizing flat panel detectors, but Keil expects that to change in the not-so-distant future.

"With all C-arm products, the leap is obviously in flat detectors and we are already seeing that in the large C-arms," he says. "I don't see that hitting the mini C-arm market until the price of those come down and that's probably still a few years away from what I can tell. We will continue to make the system more compact and easy to use for the physician and end user."

Radiation Worries

Speaking of radiation doses, another big issue surrounding C-arms in 2009 that garnered a lot of attention dealt with radiation exposure and the amount of dose that patients sometimes receive. It's a big issue in Washington D.C., and many expect to hear more about it in the year ahead.

"I think there is an increased focus on dose and that's important to take a look at," Manum says. "Customers should ask, 'How does this equipment help me mange dose and give me ways to easily track dose?' 'What is the ability to operate the system in lower dose modes, so if I choose to operate on the lowest mode, I have that within my power?' 'How does it perform and can I receive images on those lower doses?'"

Hologic Fluoroscan InSight

Usher thinks it's important for the U.S. Government to continue looking into the radiation exposure for both the patients and clinician safety.

"Certainly, it will have an impact on the entire industry," she says. "We are all working to have the best clinical images with the lowest dose possible, and there is a lot of attention to this at the moment across the industry. We want to cooperate and see how we can help. In OEC, low-dose features allow physicians to balance the clinical images they are trying to receive with minimizing the dose."

Refurbished Market

In business since 1993, Burbank, Calif.-based Imaging3 Inc. deals strictly with remanufacturing and refurbishing GE/OEC C-arms. Since the government decree shut down shipments of the industry-leading OEC products for a while, they saw a slight lag in business in 2008, but everything seems to have returned to normal.

"It hurt us on 9800 and some 9600 C-arms, as there was a shortage at that particular time, so we were doing a lot of 9000 and 9400. The 9800 and 9600 that people had they were holding on to," says Ike Balian, VP operations for Imaging3 Inc. "Today, there's an influx in 9800 and 9600 that we have access to. A lot of the C-arms were released and are now more readily available and business picked up a great deal in the last year or so."

When it comes to C-arms, overseas buyers are becoming savvy and more demanding of increasingly advanced equipment and the need for C-arms around the world has created more opportunities and a higher level of competition for used and refurbished companies.

"Business has taken leaps and bounds over the past year," says Ray Phillips, of Oklahoma City, Okla.-based Drand Medical. "By expanding our services significantly in the C-arm and radiology sector, we have been able to stay competitive and prosperous. We have been able to provide our customers with complete solutions to their end-of-life equipment needs."

For those going the refurbished route, David Denholtz, CEO of Florida-based Integrity Medical Systems, Inc., cautions that customers need to be wary.

"Most of the equipment we see being sold as refurbished is not refurbished, or even tested correctly to determine quality and performance," he says. "If you are not getting at least a one-year warranty, then do not consider the system refurbished."

Customer Concerns

Before purchasing any C-arm, an end user needs to ask some important questions to make sure that they are getting what's right for them and their facility.

"Within the operating room, customers are dealing with choices," Manum says. "They need to figure out if they should buy the new generation or the one that they are already comfortable with. They should ask about the current technology and the benefits of the image quality."

According to Manum, other important questions include: "What is the availability of service in this area?" "What is the cost of a service technician?" and "What similar technology is coming out?"

"The most important things that customers should be asking concerns themselves, as far as what their real working budgets are and what procedures the units will be put under," says Gugel. "I find that a lot of brokers and dealers push and substitute units that are of no or little use to certain doctors. This in turn creates confusion and unnecessary machines entering service."

Looking Ahead

Compared to what they were used for 20, 10 or even 5 years ago, new procedures seem to come out every month that can utilize the C-arm technology and that is a trend that is expected to continue.

"There are about 10 to 20 new procedures that are devised to treat patients with C-arms that are non-invasive and emit a low dose of radiation," Gugel says.

Philips Veradius

As flat panel detectors continue to assimilate into the C-arms market, expect a lot of new products coming out within the next few years.

Future developments also include using 3D in urology, seed placement in the lungs and using C-arms to help pain management by finding the nerve bundles with better contrast resolution.

"There's a lot of talk on 3D imagery," says Balian. "The talk has been around for a number of years now and that will be the next step for the diagnostic imaging products. We have a product that we are working on ourselves."

GE OEC 9900 Elite

Customers are also becoming more concerned with the way that everything in the room fits together and that can help drive sales of certain C-arms brands.

"The greater emphasis we see more and more of is the need for imaging products in the operating room to integrate well with everything else," Manum says. "Instead of having a C-arm from one vendor, a table from another and lights from another, customers are designing rooms that will be ergonomic and getting as much as they can from the equipment and making sure they can share data and images in that space."