Courtesy of Philips Healthcare

Special report: C-Arm technology is in a foot race

April 04, 2011

by Olga Deshchenko, DOTmed News Reporter

This report originally appeared in the April 2011 issue of DOTmed Business News

A surgeon in a brand new, $3-million hybrid operating room can be likened to a kid in a toy store. And Dr. Joseph Lombardi, chief of vascular and endovascular surgery with Cooper University Hospital in Camden, N.J., is no exception.

The hospital’s 1,300 square foot hybrid OR brings the imaging capabilities found in some of the best radiology departments right into the surgeon’s domain. Siemens Healthcare’s Axiom Artis takes care of the imaging needs in Lombardi’s OR, an impressive digital system with a flat panel detector that sweeps around the patient. (“C-Arm is kind of an old term,” Lombardi says.)

The system enables surgeons to get detailed imaging during catheter-based procedures and is vital for aneurism repairs and detections, he explains. “It’s a diagnostic tool, as well as a tool we use for treatment. It saves a lot of time and ultimately, reflects on expeditious patient care,” says Lombardi.

Since their introduction to fixed C-Arms, flat panel detectors have helped surgeons perform more minimally invasive procedures, thus reducing the length of hospital stays and infection rates. The sophistication of the current offerings not only contributes to improved patient outcomes, but also makes it easy for clinicians to embrace the technology. “It’s like driving a Ferrari,” Lombardi says of Axiom Artis. “It’s hard to argue with.”

Some manufacturers are hoping it will be hard to argue with the success of flat-panel detectors in the C-Arm market, as companies big and small are making the case for FD-based systems.

But does the latest technology pose a threat to the incumbent image intensifier-based mobile C-Arm? In today’s market, it depends on who you ask.

Move over II, FD’s here
The OEMs that currently offer flat detectors on mobile C-Arm systems say health care providers are ready to make the change from II-based units. Ziehm Imaging, the company that pioneered the concept of mobile flat-panel technology five years ago, says its customers are investing in C-Arms with the latest advancement.

In 2010, Ziehm sold 900 C-Arms in 70 countries, and more than one-third of the units were FD systems. The company recently launched the “Hybrid Edition” of its Ziehm Vision RFD system, which aims to rival fixed-room installations in its capabilities. As mobile C-Arms tend to overheat during long, complex procedures, Ziehm outfitted this system with a 20kW generator.

The mobile FD C-Arms will result in “cost savings compared to fixed-room installations,” Martin Herzmann, Ziehm’s director of global marketing, said in an e-mail to DOTmed News.

Herzmann said the technological advantages of FD systems, including a larger field of view, a reduction in distortion and a larger opening of the C-Arm for easier handling and better patient access, are also expanding the range of applications for the modality. Emerging procedures include brachytherapy, ENT surgery and craniomaxillofacial surgery, he said.

Ziehm anticipates that flat panel technology will continue to proliferate into the mobile C-Arm market. “The trend to FD technology is clear if you understand that image intensifiers still work with analogue technology,” Herzmann said. “Radiology departments around the world work with digital images –why would a surgeon still work with analogue C-Arms when he needs the best imaging quality in the OR?”

“The world is mobile and the ORs will be used in an interdisciplinary way. There is a need for flexibility in the hospital and this need will grow,” Herzmann said.

Another manufacturer that believes FD mobile technology is ready to meet the needs of caregivers is Philips Healthcare. The company shipped its first significant volume of FD systems in the first quarter of last year. “As the year’s gone on, more and more of our mix has shifted from image intensifiers to flat detectors,” says Mark Manum, director of marketing for the company’s OR channel.

To ensure a mobile system is comparable in the level of reliability to a fixed unit, Philips says it pays a lot of attention to heat management. “We make sure that our systems are optimized to perform not just in short cases, but also deliver performance through long cases and with bigger patients with dense anatomy,” says Manum.

Philips is also seeing a growing interest in the development of hybrid ORs. And many hospitals are looking at purchasing a C-Arm “as an intermediate solution or bridge, as they plan and build out a hybrid OR,” Manum says.

Philips recently introduced a new DICOM package for its Veradius FD system. “We’re also looking at some solutions related to wireless communication in the OR,” says Manum.

The company believes the C-Arm mobile market will switch over from II to FD-based systems in the near future and plans to move full steam ahead. Philips expects to have a second version of Veradius ready “by the time other flat detectors are introduced by other companies,” says Manum.

Another player in the FD mobile C-Arm field is OrthoScan. The Scottsdale, Ariz.-based company initially entered the mini C-Arm market with an image intensifier-based system in 2009. But just last year, it introduced OrthoScan FD, the first mini C-Arm with a flat detector. It’s been on the market for about three months.

When it comes to the system, users often comment on the form factor, says Anita Eaves, the company’s senior vice president of sales and marketing. Typically, a hand surgeon using an image intensifier puts it under the arm board, but an FD can go right on top of it. “What that does is reduce procedure time in a case because they’re not moving [the system] in and out; they’re leaving it in the field,” she says.

Because the flat detector can be left in the surgical field during the procedure, surgeons are also employing the system in some cases where it hasn’t been used before, such as foot, ankle and knee cases. Since it’s moved around less, there’s less risk of a breaking the sterile field, says Eaves.

Like Ziehm and Philips, OrthoScan is confident FD on mobiles is the future of this market segment. In fact, this summer, the company will launch a small, self-contained extremity imaging device with a flat detector. Weighing in at about 30 pounds, the device will be marketed towards the orthopedic office and clinic environment.

The system can be moved around in a suitcase on wheels, with wireless capability to send and receive images to devices such as the iPad. “We believe it’s the first product of its kind,” says Robert Morocco, OrthoScan’s CEO.

Step back FD, II is still king
While some vendors tout their FD mobile C-Arms, others continue to focus on and enhance their image intensifier-based systems.

In 2007 GE was locked out of the C-arm market when the FDA determined that CGMP (current good manufacturing practices with the OEC C-arm were deficient at OEC facilities in Salt Lake City, Utah and Lawrence Massachusetts. Taking quick action to correct the issues, GE has come roaring back into the market. Last year was a strong one for GE Healthcare, as it got its full-sized C-Arm portfolio back in the United States and saw a return to more than 70 percent market share, according to Elizabeth Usher, the company’s chief marketing officer for surgery.

GE says its research shows that flat panel technology works well in a fixed room but is not yet ready for mobile systems because it lacks the cooling and power boost capabilities of a fixed installation. Plus, a mobile FD system isn’t for everyone. “For some patients with smaller anatomy, you could get very good image quality with a flat panel on a mobile system,” says Usher. “But if you look at patients with denser anatomy and more difficult patients, the DQE ratio is actually better on the II for the majority of those patients.”

Joe Shrawder, the company’s president and CEO of surgery, adds that in order to obtain good image quality, an FD system may require more X-ray dose, considering the size of patients that’s prevalent in the United States and the Western world. The company says it doesn’t want to rush to the mobile FD market; instead, it wants to develop a system that can accommodate a wide range of patients with no compromise on image quality and dose.

“We would rather concentrate on the quality of care, which includes radiation dose, and go with today’s best option, which is still an image intensifier, until that superior flat panel is available,” says Shrawder.

In May of 2009, GE began shipping its OEC 9900 Elite C-Arm. By November, the company reported that it shipped more than 2,300 units across the United States.

Another II proponent, Siemens Healthcare, says its customers are asking questions about FD technology on mobile systems, but that’s as far as it goes.

In addition to the significant price difference between FD and II systems, there seems to be a lack of “clinical value” in this particular technology, says Herbert Westin, senior director, product marketing for surgery and urology with Siemens. Before investing in an FD mobile C-Arm, physicians are interested in learning about the difference it stands to make for their patients.

Siemens has most recently made improvements to its Siremobil Compact L, an II system for orthopedics, trauma surgery and general surgery applications.

Is there a final verdict?
OEMs and providers may not share the same point of view about the readiness of FD for mobile C-Arms today, but one thing is for sure – it’s the way of the future. At this time, most industry experts agree that it’s a matter of when, not if.

One of the most significant challenges to FD adoption is lack of capital. For hospitals, it means working to extend the life of existing equipment. For OEMs, it requires making a case for the long-term value of an FD system in tough times.

Still, as more OEMs enter the market with their versions of FD mobile C-Arms and the price of detectors goes down, more hospitals, orthopedic practices and ambulatory centers will have the ability to acquire the technology.

In addition to FD, physicians are also interested in dose reduction capabilities, 3D imaging and integration and wireless connectivity in the OR. Minimally invasive surgeries are expected to grow both in volume and type of procedures.

Differences between the veteran II and newcomer FD technologies aside, experts say the mobile C-Arm market will stay in good health. “There’s substantial growth ahead, particularly in markets around the world that are developing economically and are advancing in their standard of care,” says GE’s Shrawder.