photoAlthough the fixed and full-size mobile U.S. C-arm markets have matured, the market continues to grow steadily. Technological developments continue to improve C-arm capabilities, which in turn, lead to new applications. Many of those applications involve minimally invasive surgery procedures, particularly in the cardiac and neurological arenas. Orthopedic procedures and pain management — areas that also use C-arms extensively — are growing as well, primarily due to the increase in outpatient centers and an active, aging population.

C-arm Applications
C-arms are radiographic and fluoroscopic systems in which the image receptor and X-ray tube housing assembly is positioned by the C-shaped support that gives the equipment its name. Fixed C-arms can be floor or ceiling mounted, and are used in dedicated labs within hospitals.

Mobile C-arms are the portable version of the R/F systems. A monitor cart holds the monitor, digital image processing equipment and a camera. These mobile C-arms come in a variety of sizes and configurations to meet the needs of providers, ranging from doctors’ offices to hospital operating rooms. Industry research shows that full-size C-arms comprise approximately 90 percent of revenues in the mobile C-arm market and that segment is growing at 4 percent to 8 percent a year. The remaining 10 percent comes from mini C-arms, which have a smaller field-of-view of generally 3 inches to 5 inches. The mini C-arm market is growing at 4 percent to 5 percent per year.

“The market is very strong and applications continue to grow,” says John Steidley, vascular business unit director at Philips Medical Systems North America (Shelton, Conn.). Fixed and high-end mobile C-arm customers include vascular surgeons, interventional radiologists, interventional neuroradiologists and interventional cardiologists.

Frequently, these new applications come from the growing minimally invasive, catheter-based surgical techniques. For example, in September 1999 a new stent graft procedure was developed that allows interventionalists to repair abdominal aortic aneurysms, the 13th-leading cause of death in the United States. The minimally invasive procedure saves the patient from major surgery and a long recovery period, but it does require sophisticated, real-time imaging. “Being able to see the stent graft with C-arms is what makes the procedure available,” says Steidley.

Another new application spurring the growth of C-arms is uterine fibroid embolization. Steidley says one-third of the 600,000 hysterectomies performed each year are for fibroids, or benign growths, in the uterus. Instead of removing the uterus, physicians now insert a catheter and, using a C-arm, guide the catheter to the uterine artery and inject microparticles that block the blood supply to the tumor.

Other growth areas, particularly for mobile C-arms, include pain management and orthopedic procedures. As Baby Boomers age, they remain more active than previous generations. The result is a higher demand for orthopedic procedures, such as hip and knee replacements.

Fixed C-arms cost about $1 million to $2 million (much higher than the full-size mobile C-arms, which cost between $90,000 and $200,000). Steidley says the higher cost offers greater benefits, such as a larger field-of-view, more control resulting in faster procedures, superior image quality and a higher performance X-ray tube.

Cost vs. benefit
The high cost of a dedicated endovascular lab keeps it out of range for many potential users. Bas Verhoef, Philips’s business development manager for surgery, says 95 percent of the endovascular surgeries are done on a mobile system.

“People nowadays are looking for very versatile systems,” Verhoef says. “People want to have a system that is not too expensive, but at the same time, can do almost everything. Maybe 10 or 20 years ago, most people bought a mobile C-arm for orthopedic surgery and pacemaker insertions. That was about it. What you see nowadays is that most of the mobile C-arm systems can do basically 80 percent of the things that you normally do on a high-end piece of equipment.”

Michael Tullis, M.D., a vascular surgeon with Cardiovascular and Chest Surgical Associates PA (Boise, Idaho), says that while one can do the same minimally invasive vascular procedures on a mobile system, a fixed system provides additional options.

Tullis used a fixed C-arm suite in an operating room setting, when he worked at the Albuquerque (New Mexico) VA Hospital. Now at St. Luke’s Regional Medical Center (Boise), Tullis uses a Philips BV300 mobile C-arm with a 12-inch image intensifier in the operating room. He performs diagnostic studies and simple endovascular interventions in the radiology department using a standard fixed C-arm. The hospital is building a Philips fixed C-arm operating room system that it plans to use for diagnostic studies, as well as endovascular and open interventions.

A fixed system can be used for diagnostic angiography that typically is done in a radiology or cardiology suite, Tullis says. While it can be done with a mobile system, it requires special equipment and more contrast. The mobile system generally is used for procedures in which preoperative imaging has been done.

Technology Driven
As technology in high-end mobile and fixed C-arms advances, physicians can perform increasingly sophisticated minimally invasive surgical procedures. Recently introduced into fixed systems is 3D technology, which reconstructs a 3D image of the patient’s vascular anatomy. Philips’ Steidley says the technology is particularly helpful in interventional neuroradiology where it’s difficult to get a good conventional picture.

photoGE Medical Systems garnered the mobile, digital 9800 Series C-arm through its acquisition of OEC Medical Systems

So far, several hundred 3D systems have been introduced and the market is expanding. “It’s one of the reasons we think there is a lot of value in the larger fixed systems, because they have these additional capabilities. The images are just incredible,” Steidley says.

Toshiba America Medical Systems (Tustin, Calif.) also has developed a 3D fixed C-arm that the company hopes to have on the market in early 2001. The company also offers a dual-plane product, which Raymond Dimas, Toshiba’s senior product manager for vascular systems, calls two-labs-in-one. The Infinix DP has two C-arms that share a table, generator and digital system. One C-arm gives the radiologist a 16-inch image intensifier to view larger parts of the body. The other C-arm has a 9-inch intensifier for the cardiologist looking at heart vasculature.

Dimas says the dual plane C-arm plays into the team strategy adopted in hospitals today. In this approach, radiologists and surgeons of various specialties come together to determine the best course of treatment. “It has placed a demand on the market for a lab that will do more with less,” adds Dimas. “They want a lab that can work anywhere in the body.”

With the use of C-arms in endovascular procedures — which can mean using the C-arm for more than an hour — comes an increased risk from radiation exposure. “A lot of people are becoming more aware of dose,” says Philips’s Verhoef. “The lower the dose the system is generating, the better it is for both patient and staff. One of the things we try to continuously do is to get the best quality at the lowest possible dose. That is having a serious impact on sales and development.”

The concern is a driving factor in new developments in C-arm products at Philips and other C-arm manufacturers.

GE OEC (Salt Lake City), an affiliate of GE Medical Systems (Waukesha, Wis.), recently released a surgical navigation product that officials say reduces radiation exposure, improves surgical outcomes and lowers operating costs. The FluoroTrak can be purchased as an option for GE OEC’s core mobile, digital C-arm product, the 9800. FluoroTrak also works with other manufacturers’ C-arm products.

Surgical navigation allows surgeons to take a quick image and store it. The displayed image becomes a road map of the patient’s anatomy that is correlated to the real-time position of the surgical instruments. The surgeon follows the instruments’ movements without requiring continuous imaging of the patient. FluoroTrak was developed as a joint project between GE OEC and Visualization Technology Inc. (Wilmington, Mass.).

“It’s the ability to navigate your instruments against images taken previously,” says Larry Harrawood, vice president of clinical and market development at GE OEC. The technology is having the biggest impact in brain and spinal surgery, as well as in general orthopedics, such as total hip replacements.

Market dynamics
These increasingly sophisticated C-arms help drive sales in the United States where high-end systems account for 65 percent of the market, says Harrawood. The high-end equipment is needed for advanced minimally invasive surgical procedures and normally are sold to hospitals. The remaining lower-end and mid-range products are sold primarily to outpatient clinics, which increasingly provide the simpler procedures that do not need high-tech wizardry.

photoFluoroscan Imaging Systems’ Premier C-arm is in use at Washington Outpatient Surgery Center.

But the market for low-end and mid-range products remains strong in the international arena where countries are not yet performing many minimally invasive procedures. Harrawood says developed countries, such as Europe and the Asia-Pacific region, primarily purchase low-end and mid-range mobile products. He estimates the markets to be approximately 20 percent for high-end purchases, 40 percent in the middle tier and approximately 40 percent for low-end systems.

In developing countries, most facilities can afford only low-end mobile units, which account for 70 percent of sales.

Although new technologies and the growing number of minimally invasive procedures continue to fuel the market, other factors are slowing it.

“Without question, the Balanced Budget Amendment and its impact on managed care across the country and, most recently, the ambulatory patient classifications, which is essentially a reduction in reimbursements for outpatient work, has caused some hospitals to hold off on their purchase capital expenditures,” says Toshiba’s Dimas. “And that has slowed business.”

Another market factor may come from a shift in the C-arm’s function. Today, fixed C-arms are used for diagnostic angiography, as well as interventional treatments.

“What’s happening now is more and more of the diagnostic studies are replaced by noninvasive modalities, such as magnetic resonance angiography, CT angiography and ultrasound,” says Philips’s Steidley. But since physicians may be more likely to order noninvasive diagnostic studies, this trend may create a higher number of referrals to an interventional lab for treatment.

photoToshiba’s Infinix CB (above) is among the company’s C-arm products, which include the two-C-arm DP system.

St. Luke’s Tullis says that while some facilities are using noninvasive angiography, the standard of care nationwide is still diagnostic angiography.

“I think it will eventually get there,” Tullis says, “but until it does and until everybody is up to speed, comparing apples with apples, I don’t think diagnostic angiography will be out of favor.”

Mini versions
Mini C-arms, a relative latecomer to the C-arm market after debuting in the mid-1980s, cost between $30,000 to $70,000. Low-end systems are sold to orthopedic and podiatric practices for extremity imaging, while high-end products generally are installed in ORs, emergency rooms and orthopedic departments within hospitals.

Many of the same factors driving the full-size mobile C-arm market also propel the mini version, including new applications and a growing international market. Although most mini C-arms today are sold in the United States, some industry watchers say future growth lies in the international community.

Mike Sullivan, president and CEO of XiTec Inc. (East Windsor, Conn.), estimates that approximately “30 percent of the [mini C-arm] market is in North America; the rest of it is in European, South American or Pacific Rim areas.”

The growth in outpatient clinics in the U.S and abroad also spurs mini C-arms sales. That market segment requires a simpler approach, says Sullivan. XiTec recently introduced the XiScan 6000, a new system that has a selectable 6-inch/4-inch dual-mode image intensifier, a larger field-of-view than XiTec’s 4-inch and 2.6-inch products.

With a 6-inch field-of-view, physicians can image larger body parts, such as knees and hips.

Debbie Rice, material manager and OR tech at Washington Outpatient Surgery Center (Fremont, Calif.), agrees that the facility has all the bells and whistles it wants. The center owns a Premier system, a 6-inch/4-inch dual mode mini C-arm from Fluoroscan Imaging Systems (Northbrook, Ill.), a wholly-owned subsidiary of Hologic Inc. (Bedford, Mass.).

“It does everything we want it to do,” says Rice. “I can’t even think of any upgrades that I would want to see.”

The outpatient center uses the C-arm strictly for orthopedic uses, such as broken bone realignments, ACL reconstructions and removing foreign bodies. The C-arm sees about one patient a day.

Like XiTec, Fluoroscan soon plans to introduce a larger version of its traditional mini C-arm. At a 9-inch field-of-view, the new system is a full-size mobile C-arm.

“It allows us to expand into a full range of orthopedic procedures rather than just extremities,” says Carole Lee, Fluoroscan’s marketing manager. “We feel our orthopedic base is looking for that from us.”

Flat-panel future
As companies develop flat-panel technology for other X-ray products, experts predict flat panels will be incorporated into C-arms as well — but not soon. The technology is available and a few small flat-panel arrays have been installed. However, the cost for today’s flat panels overrides the cost advantages of mobile C-arms.

“I think there’ll be a day for it,” says XiTec’s Sullivan. “It will probably be at least a few years before the technology can improve to take the cost out so it makes sense to implement the flat panel in the mini C-arm.”

Full-size mobile and fixed C-arm manufacturers also are not rushing to implement prototype flat panels, in part because of the high cost, but also because the technology is not ready.

“We find there is a better trade-off with the existing image intensifier/CCD combination than there is in a flat panel,” adds Philips’s Steidley. “We think you have to give up too much in terms of image quality and dose management to utilize today’s first generation flat panels.”

Philips, which is delivering static flat-panel X-ray products, is working to overcome the technology’s limitations of today’s prototype dynamic C-arms. Other companies that have invested in flat-panel technology also are waiting for the right time to introduce it into the C-arm market. end.gif (810 bytes)