C-arm system and accessories manufacturers continue to prioritize radiation dose and exposure reduction while ensuring image quality remains high. They are using technology, including AI, along with new shielding products.

There also continue to be advances in 3D imaging as well as workflow improvements to decrease surgery times and improve patient outcomes.

Here’s a rundown of what’s new in the C-arm space from several companies.

ControlRad
Last November, ControlRad received an additional clearance from the FDA to expand its indication of use for Siemens Artis zee large detectors, in addition to small detectors, for the ControlRad Select, a radiation-reducing retrofit distributed by Boston Scientific.

“This additional FDA clearance for large detectors increases our market opportunity by more than five times,” said Guillaume Bailliard, chief executive officer of ControlRad. “This now allows us to offer our dramatic radiation reduction technology to the interventional radiology labs and expands our opportunity within cardiology as well, where there's a significant amount of imaging systems with large detectors.”

At the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting last November, the chief of cardiovascular medicine from Beaumont Hospital in Michigan presented the results of a prospective, randomized study, which found a 57% decrease in radiation exposure to the thyroid badge of the primary cardiologist, 49% reduction in radiation dose to the secondary cardiologist’s thyroid, as well as a 35% reduction in dose area product (DAP) to the patient during procedures using the ControlRad Select.

“The unique feature of ControlRad is that everyone benefits,” Bailliard said. “Patients, physicians, circulating nurses and anyone else in interventional labs all dramatically reduce their lifetime risks associated with unnecessary radiation exposure.”

GE Healthcare
At RSNA 2021, GE Healthcare showcased its OEC 3D surgical C-arm, which performs both 2D and 3D imaging in the OR. The system was FDA cleared last year.

“It had been part of RSNA in 2020, but of course that was virtual only,” said Dan Strauch, chief growth officer of GE Healthcare's surgery business. “This was an opportunity to actually have it on the show floor and was a tremendous chance to connect with customers and really demonstrate for them what we're capable of doing.

The company is seeing interest in intraoperative 3D imaging beyond the typical areas of orthopedics, and into pulmonology, for lung biopsies, and prostate cancer treatment.

“We continue to hear interest and engagement from customers around new areas that they can be using C-arms, particularly because it offers the 3D capability,” Strauch said. “We've had some customers who have purchased it only for the 2D capability because they love some of the other features that [have been] added, but it really supports workflow in that you can use it as a 2D for the two dimensional images you need through the procedure, but then as it is called for early in the surgery or later in the surgery, [it provides] a 3D image that they can use for planning purposes or confirmation purposes, which I think is a tremendous benefit.”

GE also introduced a 31-centimeter CMOS detector for its OEC One C-arm, which can be used for orthopedic and vascular procedures. It’s also been FDA cleared.

“We continue to expand the overall offering to capture more needs [with] greater capabilities to serve different types of procedures, and therefore more patients for our hospitals and our customers,” Strauch said.

Image Diagnostics
Image Diagnostics, known primarily for imaging tables in urology and vascular surgery, has developed radiation shields — the Protego Radiation Protection System and the Compass Flex Mobile Suspension System — that allow for OR imaging without requiring lead shielding for the staff. The products were released in October of last year.

“There are a lot of studies that say that [lead shielding] leads to all kinds of workplace injuries,” said Mark Hansen, vice president of business development at Image Diagnostics. “We provide an apparatus that can allow you to do a cardiac intervention, and everybody in the room can drop their lead and be safer than if they were wearing lead during the procedure.”

The Protego Radiation Protection System consists of a series of shields on the side of the table as well as up and over the patient. It can be set up in a few minutes and can accommodate a wide range of imaging angles for cardiovascular interventional procedures.

A preclinical study shows that the system reduced radiation up to 99%, Hansen said.

“And that 1% is almost not readable on current real-time dosimetry devices,” Hansen said. “So we have a number of extended cardiovascular procedures where real-time dosimetry readings start at zero and remain at zero for the entire case.”

Omega Medical Imaging
Omega Medical Imaging recently introduced Soteria.AI, a floor-mounted cardiology system. It comes with an integrated AI-based technology that automatically defines the region of interest, decreasing radiation dose by up to 84% while retaining image quality.

Soteria.AI goes beyond filtering to block the X-ray beam completely, providing radiation protection during interventional procedures,” said Dan Alred, marketing manager at Omega Medical Imaging.

“Every day, patients and staff are at risk from radiation exposure during fluoro and cine procedures,” Alred said. “Soteria.AI is something never seen before. It’s revolutionary in its performance, image quality, and radiation safety.”

The floor-mounted C-arm design of the Soteria.AI provides positioning capability normally found in ceiling-mounted systems, but with minimal down time and a lower cost of installation, Alred said.

“It also saves a facility quite a bit of money and lost revenue, because a ceiling-mounted system takes, at a minimum, six months to install, whereas this new floor-mounted system can be installed in two weeks,” Alred said.

Omega also released new software for its E-View.AI system for interventional endoscopy with a specialized quantitative measurement tool for advanced endoscopy. In bile duct stone removal cases, for example, the software measures the endoscope as a reference and then the largest stone is measured to compare to the width of the bile duct to determine the best procedure plan.

“Before, a physician had to assess the fluoro image and make a determination of how best to proceed during a case,” Alred said. “Now, they can measure everything precisely and it makes the stone extraction much simpler and more efficient.”

Parker Medical
At last year's RSNA, Parker Medical showcased its line of C-arm high-voltage cable harnesses, interconnect cables, power cords and X-ray tube shields.

Parker Medical has developed a new ergo high-voltage cable harness for motorized 3D-imaging C-arms. It allows for increased C-arm maneuverability and improved C-arm rotation positioning to view challenging areas, said Christine Holland, vice president of business development for Parker.

“The HV cable harness is critical to C-arm operation, supplying power to the X-ray tube and interconnecting all the associated C-arm components,” Holland said. “Parker’s HV cable harness technology serves to support C-arms performing procedures for critical ER care, to vascular, orthopedic, pain management and more.”

The cable harnesses are high-voltage tested to 125 kV and undergo other interconnect tests to ensure they are ready to perform reliably upon installation at the factory or site, Holland said.

Parker offers other products for C-arm equipment, including X-ray tube shields made of high-density plastic to reduce radiation scatter, protect patients and staff and to replace the need for lead shielding at the X-ray source.

Philips
Last year, Philips released an integration for its Azurion FlexArm hybrid OR solution with the Hillrom TS7500 table. Previously, the system was compatible with the OR tables from Getinge.

The system is aimed at surgeons and physicians who work on a range of procedures in hybrid OR environments.

“That’s where the OR becomes very important, because the same OR table [would be used) both in a minimally invasive interventional procedure and open surgery,” said Niranjan Narayan, director of product marketing systems and software for image guided therapy at Philips. “Vendor standardization is important for some of our customers. They might have other tables in their other operating rooms, and they don't want to switch vendors only for your interventional hybrid OR space. So it is important to maintain that flexibility for our customers, and ensure that they can continue to use the vendor of their choice.”

The company has also released APC Pathways on their FlexArm systems, a feature that allows clinicians to automatically recall the system to a working position via a particular trajectory.

“It's very helpful, especially in these OR environments when you want to switch to an interventional procedure; you've got to get the C-arm back near the table, and these OR rooms are fairly crowded sometimes, and you have a lot of equipment,” Narayan said. “Customers can now define and store pathways or trajectories, through which you can easily recall the C-arm from what we call the parking position away from the table to the working position, all with a single button. This is helpful in efficiency.”

In the mobile C-arm space, Philips announced several updates for its Zenition platform. The system now comes with a larger FD 30-centimeter-by-30-centimeter detector, which uses advanced image processing algorithms to provide enhanced visibility of fine anatomical details during procedures. Its expanded coverage enables physicians to view 33% more anatomy in one image, reducing the number of images taken and decreasing radiation dose.

Along with the new detector, Philips integrated Cydar EV Maps software into the Zenition platform, adding procedure planning and real-time 3D guidance capabilities to the mobile system.

Also for the Zenition, the company released a table-side user interface integration that allows clinicians to operate the C-arm inside the sterile field. This helps reduce the communication burden with the operator. In another workflow improvement, the Zenition platform also now integrates intravascular ultrasound for peripheral vascular procedures.

Philips also released its StentBoost technology, which enhances visualization of the stent to show fine details of stent struts and thinner and drug-eluting stents, supporting surgeons in more precise placement.

Siemens Healthineers
In July 2021, the FDA cleared the integration between the Siemens Healthineers Cios Spin 3D C-arm and the NuVasive Pulse Platform. The combination, which stems from a partnership announced in 2018, is designed to improve the workflow and outcomes for minimally invasive spine surgery.

With many different companies creating solutions for minimally invasive spine surgery, the different technologies require different workflows, said Allison Sutter, advanced therapies surgery marketing manager at Siemens Healthineers North America.

“Together with NuVasive we're able to provide an integrated solution, inclusive of Cios Spin’s 2D and 3D imaging, and the Pulse Platform’s dedicated spine surgery technologies,” Sutter said. “The Cios Spin and NuVasive Pulse Platform now seamlessly integrate, delivering 2D and 3D imaging, navigation, radiation dose reduction and dedicated spine surgery technologies from one easy-to-use platform.

“Now, with this integrated solution, there are no more trade-offs between invasiveness, efficiency and radiation exposure,” Sutter said. “There is now a single solution for minimally invasive spine surgery.”

Turner Imaging Systems
Over the last year, Turner Imaging Systems has improved the battery technology on its Smart-C mini C-arm. The system comes with two lithium ion batteries that each provide eight hours of use and come with rapid charging, with full charging for both batteries in about 90 minutes.

“So you don't have any need to charge it during the work day,” said Roberto Scorcia, vice president of sales and marketing for Turner Imaging Systems. “What it is enabling our customers to do is use the Smart-C in all sorts of care environments, including military bases and emergency disaster relief.”

“The improved batteries have improved lifetime and cell capacity,” said Mike Orthner, director of business development for Turner Imaging Systems. “Advanced cell balancing ensures differences between the cells are as small as possible, improving overall pack performance and capacity over time.”

In addition to the battery upgrade, software updates to the Smart-C include enhancements to cybersecurity.

The company has also worked with the Foot & Ankle Research Innovation Laboratory (FARIL) at Harvard, which conducted a study comparing image quality and anatomical measurements from images acquired by the Smart-C and DR systems.

“You may not need to have a dedicated X-ray room and wall power of 240 volts for these big strong DR systems, you don't need lead shielding,” Orthner said. “You can free up, potentially, a lot of time by bringing simple cases into the clinic.”

Based on the study, the company learned that it needed to develop a weight-bearing stand to take AP and lateral shots of the foot and ankle with the Smart-C. The product is in final testing and is due to be released this month.