Siemens Cios Alpha
Mobile C-arms: Is the era of flat panel detectors and 3-D technology upon us?
March 10, 2016
by Lauren Dubinsky
, Senior Reporter
The global fluoroscopy and mobile C-arm market was valued at $1.69 billion in 2012 and is projected to be worth $2.08 billion in 2019, according to a Transparency Market Research report. The growth is mainly being fueled by a rising demand for interventional radiology procedures. The field of interventional radiology is growing predominantly due to the fact that there are new types of minimally-invasive procedures emerging. There has been a transition from open aortic surgery to minimally- invasive surgery as well as a trend toward endovascular cancer care.
GE Healthcare and Philips Healthcare have recently come to market with a plethora of tools for fixed C-arms to assist with those types of procedures. The tools have already been proven to shorten procedure time, reduce the amount of contrast needed and improve sensitivity.
But the biggest trend in the market is flat panel detectors (FPDs) and when they will become the standard for mobile C-arms. Image intensifiers (IIs) are still the mainstream technology, but industry experts believe that will change in the not-so-distant future.
Flat panel or image intensifier?
Ziehm Imaging introduced the first C-arm with a FPD in 2006, and since then many other manufacturers have followed suit. Philips received FDA clearance for its Veradius Unity in November 2014, which is its third generation FPD system, and Siemens Healthcare introduced a new FPD mobile C-arm at last year’s Radiological Society of North America (RSNA) meeting.
Despite the influx of FPD mobile C-arms, IIs still remain the industry standard. The main reason for that is cost — a standard C-arm with a FPD costs between $280,000 and $300,000, and standard systems with an II cost between $120,000 and $170,000, according to MD Buyline. “It mainly depends on [whether] a facility has the money to budget for a flat panel system,” says Jamie Dildy, clinical analyst at MD Buyline. “That would be your bigger hospitals and facilities that are using the C-arm all of the time.”
Another reason that FPDs have not caught on in the marketplace is because the market leader, GE Healthcare, hasn’t introduced a mobile C-arm with the technology yet. GE’s OEC systems are the most popular C-arms on the market, according to MD Buyline. “It’s not that we don’t know this technology well, but because we know it well, we recognize that we did not feel it was the right technology to put on a mobile C-arm in its current state,” says Linda Milano, regional product marketing manager of surgery at GE.
However, GE is currently working on its own FPD technology and will introduce it to the marketplace at some point in the future. Many industry experts believe that once GE introduces its C-arm with an FPD, the industry will start to move away from IIs. Even though FPDs have not gained popularity among the full-size mobile C-arms, they are popular among the mini C-arms used for orthopedic imaging. One reason is that the price of mini C-arms with FPD is significantly less than the price of full-size C-arms with FPD.
OrthoScan and Hologic are two manufacturers that offer mini C-arm systems. OrthoScan has recently been pushing FPDs heavily in the market and has been successful with it, according to Matthew Blaustein, founder and CEO of Bluestone Diagnostics. “I think if a customer has money, they will buy the flat detector. You see the flat detector being a much more viable option than it would be on the large C-arms,” says Blaustein.
Coming to you in 3-D
In April, Ziehm received FDA clearance for its Ziehm Vision RFD 3D C-arm, which is the only 3-D C-arm with an FPD that provides a 16-centimeter edge length per scan volume, according to the company. Its flat panel is 30 centimeters by 30 centimeters and the system is ideally suited for orthopedics, traumatology, spinal injury as well as cardio-vascular hybrid applications. It also includes Ziehm Smart-Scan technique, which provides 180-degree image information of any anatomical structure.
Along with many other modalities including mobile CTs and O-arms, 3-D C-arms are entering the surgical operating room. The O-arm costs significantly more than a 3-D C-arm. The O-arm can cost up to $1 million, depending on the configuration of the system, but a 3-D mobile C-arm can cost around $500,000, according to MD Buyline. The other 3-D C-arms on the market are Siemens’ Arcadis Orbic 3D, which was introduced in November 2011, and Philips Healthcare’s BV Pulsera, which received FDA clearance in September 2006.
Lisa Reid, director of surgery and urology segments for Siemens, thinks that the industry will start to become more interested in 3-D technology in the OR in the near future. Since the 3-D C-arms can be used for 2-D and 3-D imaging, it’s more versatile than having a CT scanner in the operating room and you can use the 3-D C-arms for a variety of different procedures. “These are the types of technologies customers want — they want to be mobile, they want to be flexible, they want to be versatile in the OR, and save costs, but they need these more advanced-type technologies like flat panel detector and 3-D,” says Reid.
New on the market
At last year’s RSNA meeting, Siemens introduced three new additions to its Cios family of C-arms — the Cios Fusion, Cios Connect and the Cios Select. Cios Fusion and Cios Connect are still pending FDA clearance, but Cios Select received clearance in mid-January.
“We wanted to update our entire product line to suit the current market because a lot of our customers are looking to cut costs, but as well, they need good C-arms for things like backups to their interventional labs and hybrid OR labs,” says Reid. The Cios Fusion has an FPD and a field of view about 160 percent larger than Carms with standard IIs, according to the company. This system is ideal for orthopedic surgeons because they are imaging the hips and knees and want smaller systems to be able to maneuver them into different positions.
The Cios Connect has II technology and covers a broad range of applications in the medium market segment. It has low service costs and it is geared toward facilities that are more budget-conscious and looking for a C-arm that does a little bit of high-end applications, but mostly basic surgery. The Cios Select also has II technology and was designed for routine clinical use to provide easier access to surgical imaging. It’s mainly for outpatient and pain management clinics that perform basic procedures.
Starting in January, Siemens introduced an expanded version of its Cios Alpha. It has the revised version of the Cios software, a large preview image on the touch-screen, and metal correction functions for metal components in the image.
Interventional procedures are growing
There is also a great deal of innovation taking place among the fixed C-arms that are used in cardiac catheterization labs. Both GE and Philips launched new products last year to shorten the procedure times and improve outcomes. “The devices and the techniques applied in interventional radiology are really growing and allowing for more interventional procedures versus open surgery,” says Miranda Rasenberg, global interventional marketing manager at GE. “You see it predominantly growing in those two areas — the vascular surgery area and interventional oncology.”
At last year’s RSNA meeting, GE introduced its new ASSIST software packages for interventional imaging. The packages include Vessel ASSIST for interventional radiology, EVAR ASSIST for vascular surgery, Needle ASSIST for bone interventions and Valve ASSIST and PCI ASSIST for interventional cardiology. GE is also adding its FlightPlan for liver embolization to the portfolio.
They help to plan, guide and assess the most complicated procedures that interventionalists and surgeons are performing today. GE’s FlightPlan, which has been in clinical use for four years, has been shown in clinical studies to help clinicians better identify tumor-feeding vessels. The studies found that it provides up to 97 percent improved sensitivity in identifying tumor-feeding vessels. In addition, when using the software, there was an 11 percent reduction in procedure time, and 82 percent of radiologist readers agreed on the identification of liver tumor-feeding vessels.
In April, Philips launched its VesselNavigator for its interventional X-ray systems including its fixed C-arms. It’s Philips’ latest innovation in live 3-D catheter navigation to guide minimally-invasive treatments of patients with vascular diseases. In studies, it has been shown to reduce the need for contrast by 70 percent and has shortened procedure times by 18 percent.
VesselNavigator can be used for all types of endovascular procedures, but one of its main applications is guiding the treatment of aortic aneurysms. It’s difficult to precisely position the stent when using conventional X-ray imaging, which leads to more contrast being used. VesselNavigator works by fusing live X-ray images and MR and CT images of the patient’s vascular structures. That gives the clinician 3-D, color-coded images of the vessels, which improves real-time visual guidance.
What’s to come?
Siemens’ Reid and Ronald Tabaksblat, business leader for image-guided therapy systems at Philips, believe that 3-D imaging will become more popular in the OR. Jason Launders, director of operations at ECRI, agrees that there is a big need for 3-D in the OR. “I believe the possibilities of 3-D and CT like imaging on a C-arm are underutilized,” says Tabaksblat. “Imagine a trauma patient not needing to be transported first to a CT and subsequently to an interventional lab, but being sent directly to a hybrid OR specifically tailored for this type of patient? Wouldn’t that provide major benefits in time to treatment and less risk of moving the patient?”
GE’s Molani thinks that a bigger shift in the marketplace will be in terms of efficiency. “I think the universal need is going to be efficiency and workflow, so that is where we will be focusing more of our attention,” she says. ORs are usually crowded, with an abundance of equipment that is necessary, but poses ergonomic and safety concerns for the hospital administrators, directors, staff and surgeons. GE is focusing on OR integration to make sure that all of the elements of the OR, including C-arms, work together seamlessly.
Most of the experts interviewed agree that FPD will become the standard for mobile C-arms in the future. Cost is one of the main hurdles standing in the way, but that will no longer be an issue when the price of the technology goes down. “Image intensifiers will become increasingly expensive and the flat panels will come down in price. They are coming down in price in other areas, so they will come down here,” says Launders.