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Gradual recovery looms for surgical X-ray market

With the steady return of elective procedures and as healthcare expenditure is restored, recovery is forecast to be gradual rather than V-shaped.

With the postponement of non-essential elective surgeries and medical procedures in 2020 to conserve medical resources for COVID-19 patients during the start of the pandemic, cardiovascular procedures were severely impacted. The increased costs of caring for COVID patients, personal protective equipment (PPE) and the loss of elective procedure revenue caused a massive financial burden on healthcare providers. This is expected to result in reduced capital expenditure budgets for imaging equipment, including interventional angiography imaging systems and C-arm X-ray systems.

The world markets for the imaging systems are estimated to have declined by 17.4 percent for cath lab angiography systems and 16.3 percent for surgical mobile C-arms in 2020, according to a report from Signify Research. However, growth in this market is predicted to return from 2021 onward as the negative impact of the pandemic is expected to subside. Recovery is forecast to be gradual rather than V-shaped, with the steady return of elective procedures and as healthcare expenditure is restored following the diversion to COVID-related equipment.

From 2021 onward, there is expected to be pent-up demand for both interventional and surgical X-ray systems. The market for fluoroscopy systems and mobile C-arm fluoro systems is expected to reach almost USD 3.9 billion by 2024.

Demand for image intensifier mobile C-arms was less impacted than for flat panel detector (FPD) equivalents in 2020 due to COVID-19, as providers focused on cost-effective equipment due to reduced capital budgets.

In the surgical X-ray market, FPD 2-D mobile C-arms are forecast to have the fastest growth through to 2024, with a compounded annual growth rate (CAGR) of 3.4 percent. In 2020, there was a shift toward low-end to mid-range FPD 2-D systems as a result of stretched capital expenditure budgets. Demand for image intensifier systems is slowing down, with the key markets now in the emerging market regions of the world. However, in developed markets, such as the United States, usage of imaging intensifier systems is still high in pain management clinics.

3-D mobile C-arms are primarily used for imaging the joints, spinal fusion, and fractures and the market is expected to start seeing signs of recovery from 2021 onwards, following the return of elective spinal procedures to pre-pandemic levels. Countries with the highest adoption of 3-D surgical X-ray imaging include China, Western Europe, and the United States.

Within the interventional X-ray market, the interventional cardiology (IC) market was more negatively impacted by COVID-19 than interventional radiology (IR) due to heavier reliance on elective procedures. An increase in the number of structural heart procedures performed, in particular percutaneous coronary intervention (PCI), continues to be a factor maintaining clinical demand for the IC market. The IR market has experienced a continued expansion of clinical procedures being performed. An increased incidence of peripheral vascular disease is driving demand for general vascular angiography. Despite an estimated 26 percent drop in the hybrid operating room segment in 2020, fastest growth is predicted for this product category through to 2024.

Market trends
The North American market has been significantly impacted due to postponement of non-critical surgeries, and as budgets for non-diagnostic X-ray equipment were diverted to COVID response. The North American market will be driven by replacements of existing equipment and increasing demand from outpatient clinics and facilities.

Brazil has been one of the worst impacted countries globally by COVID-19, resulting in a severe market retraction for both the interventional and surgical X-ray markets in 2020.

The Western Europe market is forecast to experience pricing pressures from 2020 onwards, with the economy suffering as a result of high COVID-19 impact. Recovery is expected to be steady and gradual through to 2024 as economies struggle with the impact of the pandemic.

The Saudi Arabia-Russia oil price war and the COVID-19 pandemic have further setback the prospects of a recovery and the market is forecast to sharply decline in 2020 by 20.1 percent. Postponement of elective procedures contributed to the huge drop in demand in 2020.

The Chinese market has had one of the quickest recoveries from the COVID-19 pandemic globally, with a forecast contraction of high single digits in 2020 for the surgical X-ray market. Demand for hybrid operating rooms and 3-D mobile C-arms is high in China, mainly in high-end hospitals.

FPDs gaining momentum
With major producers of CCDs shutting down manufacturing factories, the gradual shift away from CCD Radiology Imaging Units (RIUs) has been rapidly sped up and obsolescence of these units is imminent. CCD image sensors are a key component of camera lens assemblies that, together with an image intensifier, forms an RIU used for X-ray imaging and have been a staple in C-arms for decades.

However, recent shifts in the manufacturing have left the future of C-arm technology for economy systems up in the air as CCD sensors face obsolescence. The gradual shifts in healthcare have slowly moved the field away from CCD C-arms toward newer imaging options, such as FPDs, and this shift has begun to gain momentum.

FPD C-arms an emerging trend

RS Kanwar
Additional Managing Director,
Allengers Medical Sytems Ltd.

C-arm being a fluoroscopy X-ray equipment used to see the anatomy in real time, remained the most versatile and indispensable medical equipment during most of the medical surgical procedures since its invention. Based on technology, the market is categorized as image intensifier C-arms and flat panel detector C-arms (FPD C-arms). Flat panel detector (FPD) is increasingly replacing image intensifiers (II) on mobile C-arm systems.

Currently, two major FPD technologies have been implemented, based on indirect conversion of X-rays to light (using an X-ray scintillator) and then to proportional charge (using a photodiode), or direct conversion of X-rays into charge (using a semiconductor material) for signal acquisition and digitization. This equipment provides real time images required in various surgical procedures. At times a high quality digital SPOT can also be taken by the surgeon. SPOT gives excellent image at much lower dose.

FPD based C-arms are mainly divided into surgical and vascular segments. Surgical segment mainly caters through 20×20 or 21×21 size FPDs with low to medium power X-ray generators. Vascular segment uses 30×30 FPD.

The larger FOV makes it possible to see a larger part of the body and thus allows you to perform the procedure in one shot. Even few equipment are designed with very high power X-ray generators with 43×43 size of FPDs for vascular procedures related to the lungs and abdomen. All vascular equipment generally come with DSA, roadmap, and peak opacification as standard built in features. Revolution in vascular and surgical procedures is just at the doorstep with latest FPD technology. High speed, better resolution, and better low dose performance are the area of thrust in FPD development. Better technology FPDs will make medical procedures more accurate and safe for human beings.

Due to the inherent technical features there is a limit to what an image intensifier (a vacumatic component) can accomplish as compared to a FPD (a solid state component).

For the comparison, consider flat screen TV vs a telescope. The flat screen provides a wide image that allows you to cover wide portions of the patient’s anatomical structure as needed. The telescope can provide a fantastic image too, but you have to point it precisely or pull back sufficiently far in order to get the image you need within the viewer. So the time today, is knocking on the doors for FPD C-arms.

In 2020, ON Semiconductor, formerly Kodak, announced the closing of its CCD factories, which follows Sony’s CCD shutdown a few years ago. CMOS sensor performance is catching up or even surpassing the performance of CCD’s. The largest manufacturers of CCD technology are no longer producing, with very few options left.

Alternatives, such as CMOS-based cameras, are not worth redesign efforts due to significant time and cost investments of implementing a new product in preexisting RIU’s. Many companies now have to complete last time buys as they determine next steps which works in the short term to keep CCD units in the field. However, most last time buys only allow for a run time of 2-4 years to continue to use CCD and maintain service needs.

This sped up obsolescence is also moving along due to natural trends in the healthcare field. CCD RIU’s have been the main technology in C-arm units for multiple decades, and they still hold a strong position in cost-sensitive C-arm applications. Other key innovations are taking its place in these cost-sensitive applications, such as more advanced diagnostics known from high(er) end systems, and FPDs.

The emergence of new technology is partnered with a new generation of doctors who are more receptive to changes in diagnostic images. This combination leads to reexamining what is currently being used and overhauls in existing systems. New RIU systems will provide multiple benefits, such as distortion-free images, higher contrast range, and better image sharpness. The shift away from CCD cameras to FPDs also prevents obsolescence from becoming an issue in healthcare. The question is: which flat detector technology is capable of replacing CCD-camera based systems while maintaining a balance of image quality, dose, and price?

Finding alternatives now, rather than when last time buys run out, allows for a more gradual transition. This also prevents the struggle of having to do so when the need becomes dire. These alternatives need to be part of the new generation of technology that is growing in the healthcare field, as CCD sensors are disappearing. The key alternatives to CCD cameras are CMOS, Amorphous Silicon (aSi) flat panel detectors, and Indium Gallium Zinc Oxide (IGZO) flat panel detectors.

Vendors update
Allengers. Recently, the company has introduced top-end indigenously developed high frequency C-arm’s with the FPD. The Digiscan Series are intended to provide fluoroscopic images of the patient during diagnostic, surgical procedures. Due to its high image quality and easy maneuverability, it enhances the overall workflow in all the applications.
Fujifilm Medical Systems. In November 2020, the company has entered the surgical and fluoroscopy markets with two new systems: the Persona C surgical C-arm and Persona RF Premium System. These systems have the ability to provide digital X-ray imaging studies and fluoroscopy exams, allowing physicians to enhance workflow and assess their patient’s condition. Persona C surgical C-arm is an advanced imaging solution engineered for fast, precise positioning and advanced image quality across a broad range of diagnostic imaging and minimally invasive surgical procedures. It will be available with 21x21cm or 30x30cm amorphous Silicon (aSi) flat panel detector options for ultra-low dose fluoroscopy and vascular imaging.

GE Healthcare. GE Healthcare’s OEC One CFD compact mobile C-arm with CMOS flat panel detector (CFD), which delivers a clear view of the anatomy across procedural settings in a synchronized, all-in-one workflow has been gaining preference. Image quality is essential across procedures and procedural settings, especially in tight spaces. With OEC One CFD, clinicians receive the image quality expected from OEC mobile C-arms and the clinical versatility needed in a compact mobile C-arm. Its all-in-one workflow helps optimize surgical space with a connected display on the one-piece C-arm. It synchronizes workflow with a touch control panel, and streamlines the clinical team’s communication for faster image adjustments. All OEC C-arms are designed to provide fluoroscopic and digital spot images of adults and children during diagnostic, interventional, and surgical procedures.

Philips Healthcare. In 2020, Philips announced two major innovations on its Zenition mobile C-arm platform. With a new table side user interface, clinicians can operate the C-arm inside the sterile field, reducing communication issues with the operator and making it more intuitive to control the system. In addition, the Zenition platform has been extended to integrate intravascular ultrasound (IVUS) for peripheral vascular procedures, streamlining the operating room (OR) and improving workflow.

The scope and complexity of surgical interventions — especially in the rapidly growing area of image-guided minimally invasive surgery — continues to increase, as does the number of patients requiring treatment. Mobile C-arms are X-ray systems that are brought into the OR to provide live image guidance during a wide range of surgeries including orthopedic, trauma and vascular procedures.

The Zenition mobile C-arm platform brings together innovations in image capture, image processing, ease-of-use, and versatility pioneered on Philips’ Azurion platform. By integrating the table side user interface with the Zenition system directly at the table, the clinician can control the system through its tablet-like user interface. With a large 12.1-in. display, the table side user interface can be positioned at a range of angles and can also serve as a viewing monitor on the patient table.

Siemens Healthineers. Siemens Healthineers is focusing on touted its Cios mobile C-arm series as an option for lung imaging. The mobile C-arms can be positioned flexibly according to the imaging needs in standing, sitting, or lying patient positions. The systems offer antimicrobial coating, smooth and closed surfaces, and approved cleaning and draping protocols.

In order to safeguard optimal surgical outcomes and be able to perform intraoperative corrections to avoid postoperative complications, surgeons greatly benefit from intraoperative tools that let them confirm their planned results. Cios Spin enables precise intraoperative quality control based on dedicated 3-D technologies, allowing surgeons to confirm their results.

Orthoscan. The company launched its Tau 20/20 mini C-arm for surgery in 2019, offering the lowest dose available for a mini C-arm. It has FDA indications for pediatrics and uses a 20×20-inch flat panel detector.

Key takeaways
In India, local X-ray manufacturers were spearheading the uptake of both surgical and interventional X-ray systems pre-COVID. Within the mobile C-arm market, Kiran facilitated the uptake of low-end 2D FPD mobile C-arms from 2019 onwards, offering more affordable FPD solutions than global vendors. As a result, the Indian market is gradually shifting from predominantly image intensifier systems to a higher presence of 2D FPD technology. In a similar manner, Innvolution Imaging is accelerating the uptake of cath labs in rural areas of India, making cardiovascular care more accessible and affordable to the wider part of society.

C-arms offer the optimum angle to achieve high-quality images, and also allow for easy movement and positioning within the patient room, while at the same time keeping the patient comfortable. The maneuverability and precision of C-arms provides clinicians with immediate copies of images, which is helping to expedite its market growth. Market growth is also attributed to the rising geriatric population, which has a high susceptibility to chronic conditions such as cardiovascular, orthopedic, and respiratory diseases. This, coupled with increasing patient awareness, is expected to drive the market growth in coming years.

Augmented reality is expected to be at the forefront of state-of-the-art hybrid operating rooms, in order to aid procedural navigation, reduce operating times, and radiation exposure. Real-time navigation data can be used to enhance patient outcomes using holographic images, as well as having full visibility of the operating room. Within image guided therapy, 3D scan images, segmentations, and measurements can be layered on top of the patient directly in the interventional suite for real-time clinical decision support, as well as preoperative planning.

3D mobile C-arms are forecast to have the highest adoption in China, Western Europe, and the United States. The Chinese market accepts the benefits of 3D mobile C-arms from a navigational and clinical perspective.

In contrast, the United States market is a challenging market for 3D mobile C-arm system manufacturers to penetrate due to the extensive use of Medtronic’s 0-arms in minimally invasive spinal surgery, also offering navigational capabilities.

The multi-disciplinary use of hybrid operating rooms (HORs) is facilitating uptake through to 2024, as healthcare providers tightly monitor return on investment, and usage statistics to better inform purchasing decisions. Despite the initial higher associated cost compared to dedicated interventional X-ray systems, the increased profitability and the flexible utilization is fueling uptake in developed markets. Usage of HORs is predominantly in cardiac surgery, followed by vascular procedures, facilitating enhanced clinical precision and patient outcomes in more complex cases.

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