Viewing the imaging market — Interventional X-ray and angiography

April 08, 2024
By Tom Watson

Interventional X-ray continues to be a strong and stable market in 2024 and is likely to remain stable and continue growing. While other medical solutions are competing in one manner or the other, catheter-based angiography will continue to be the gold standard for diagnostic and therapeutic intervention for vascular disease in the heart, the body, and the head for the foreseeable future.

This specialized and unique radiation-based imaging solution provides both diagnostic and therapeutic solutions for cardiology, vascular, neurology and combinations of these clinical specialties. Technology has evolved to allow the same core systems with optional software and hardware features available to address each specialized need. The medical markets are addressed by specific variations of design, single-plane imaging, or biplane imaging. These core gantry orientations offer floor or ceiling-mounted options with some specialized systems allowing a floor-based unit that is not fixed but can move around the interventional suite.

While the market is strong, it still lags the demand seen prior to the COVID pandemic. Certainly, capital budgeting and buying is still on a more conservative curve than pre-pandemic. Also, it appears many users are now in more of a replacement/upgrade market rather than net new system purchase. However, the major players remain constant: Canon Medical Systems, USA, GE Healthcare, Philips Healthcare and Siemens Healthineers are the four strongest vendors in the U.S. market. Shimadzu Medical Systems has been a fifth-place competitor but remains a distant consideration.

The symplr Capital Spend database is a real-time, dynamic database reflecting customer interest in specific vendors and specific models based on quotes submitted for analysis. This provides a time-proven reflection of the mindshare of healthcare organizations considered for purchase.

The historical quoting and purchasing patterns show customers considering this solution about 61% annually compared to 2019-2020 (pre-COVID). However, the past 12 months show a gradual increase from year to year. Data from symplr’s database reflect Philips, at 43%, as one of the most highly considered vendors overall, with Siemens (27%) and GE (23%) trailing and Canon at 7%. These percentages can vary depending on the specific system orientation.

• Single-Plane Ceiling-Mounted: Philips 63%, Siemens 29%, Canon 8%
• Single-Plane Floor-Mounted: Siemens 35%, GE 35%, Philips 25%, Canon 4%
• Biplane Systems: Philips 41%, Siemens 34%, Canon 14%, GE 10%

*Note: GE Healthcare does not offer a single-plane ceiling-mounted solution. However, GE offers a unique design with their IGS 7 series. It is a floor-based system that can move around the patient table via laser guidance.

Replace versus “upgrade”
The last few years have seen several vendors offering an “upgrade” path to existing customers. While the offer is presented as an upgrade, it is more something referred to as a “forklift upgrade”. In principle, the offer may be designed to use the structural base of the imaging system (gantry) and replace all internal components, mechanical, electrical, imaging chain and software. In some cases, the vendor opts to simply pull out the old system and replace it with a new system, thus, the “forklift” terminology. About 26% of Philips quotes we have seen in the past 12 months represented as a “Catalyst Upgrade”. Siemens presents their upgrade solution as an EVOLVE promotion. Both are effectively a new system, being presented as an upgrade. Often, there is not much, if any, difference in these upgrade offers versus a new system with an offer to take the older system back and provide a trade-in credit.

High-interest clinical applications

Radiation dose reduction & management
All active vendors have very strong and focused solutions to provide optimal imaging with the least amount of radiation necessary. They have standard software to monitor and alert staff when radiation exposure is high or above normal operational limits. The variables that determine radiation exposure are highly complex, involving patient size (body mass), imaging techniques/settings, length of procedure, and procedure and/or physician protocols and preferences. While many vendors claim superiority in dose management and dose reduction, the variables outside of the system design ultimately impact the dose. This aspect of this technology requires all aspects to be closely monitored and followed by the manufacturer and their design, by the radiology operators and by the interventional physician and their use of the system.

Hybrid IXR/Surgical Labs – Mostly cardiac-based, this is specifically designed for the growing therapeutic area for minimally invasive structural heart, which includes catheter-based versus open-surgical based treatment for cardiac valve disease. The option to forego surgery to address heart valve disease continues to grow and gain FDA approval for an increasing patient population. Clinical studies continue to compare cost, long-term outcomes, recovery times and patient preference. However, many organizations have opted for specialized configurations to allow this procedure. This specialized area has moved toward a more traditional interventional design versus the original hybrid surgical/interventional design.

• The need to allow more access to the patient’s head in critical situations has driven some of the IXR system designs. The need to be able to maintain a clear space above the patient if surgical intervention is required has also been a factor. The surgically focused solutions from all vendors have systems that offer specialized options i.e., Philips Azurion C20 FlexArm, Siemens’ ARTIS pheno (unique floor-mounted design) and GE’s iGS 7 Series. While these are ideally designed, some continue to use traditional ceiling mounted systems primarily.

Image Guided Oncology – This is part of interventional radiology configurations that will assist in specifically guiding oncology interventions using IXR. This has created a resurgence of interventional radiology suites that had largely been combination cardiovascular, driven by cardiologists that expanded outside the heart for peripheral angiography applications (excluding neurology). Often ultrasound guidance will also be part of this application.

Electrophysiology (EP) – The IXR is designed to allow specific placement of specialized EP catheters to diagnose and now therapeutically treat abnormal cardiac electrical signals. There continues to be some evaluation of whether single-plane (diagnostic) or biplane (therapeutic) configurations are the best option for EP procedures. Some therapeutic requires 3D mapping of specific pathways and ablation requiring precise identification and placement of ablation catheters.

Pediatric/Neonates/High renal failure patient population – Biplane has been the standard for this patient population. Biplane allows simultaneous imaging from two orthogonal planes (90 degrees) providing imaging of complex abnormal anatomy. It reduces the amount of contrast material, as limiting volume is critical in small patients as well as a patient population with a high percentage of renal failure. Advances in 3D imaging/reconstruction are helping and may move more of this population to single-plane options with advanced 3D capacities.
CT Angiography (CT-Like) – Provides better visual representation of anatomy and orientation of structures. This is playing a significant role, especially in the transcatheter valve sizing, positioning, and placement. It is also key in evaluating the success of the procedure to reduce the potential for leakage or post-procedure complications.

Associated technologies
Intravascular Ultrasound (IVUS) – This specialized catheter-based ultrasound and intra-luminal pressure solution provides precise data that can determine if placement of a stent will provide improved patient outcomes. By measuring the pressure on either side of a lesion (blockage), the resulting metric can provide clinical justification for placement of a stent or insufficient justification for stenting, which can be a significant cost determination for both the hospital, patient, and insurance provider. The pressure measurement is known as Frequency Flow Reserve (FFR).

Cardiac CT and CTFFR have a growing level of interest. The primary reason is that CT remains a noninvasive solution, which can be preferred if being used to screen patients that are suspected of coronary artery disease. It would help ensure patients with unclear or marginal risks do not need an invasive diagnostic procedure. The CT is purely diagnostic and if it provides sufficient proof there is disease, the patient must then undergo the invasive procedure to verify if there is need to therapeutically treat the condition. It may also require referring the patient to surgery depending on the specific findings. The other challenge is that the patient is typically exposed to higher radiation levels with CT than with IXR. This may still evolve into a noninvasive option to rule out coronary artery disease in younger patients, as well as those with marginal risk and without other symptomatic signs.

Hybrid Angio/CT solutions – There are a few offered by Siemens and Canon. symplr’s history of customer interest suggests these are not widely considered by mainstream healthcare providers. When they are, the customer profile tends to be University/Teaching/Research facilities. The cost is prohibitive for mainstream hospitals both in terms of capital costs and post-warranty operational costs, as well as staffing and other related operational costs.

Future vision & decision
Artificial Intelligence (AI) – The interventional procedure relies heavily on a large intake of visual and empirically measured data, as well as 3D/4D image reconstruction and output. Decisions are largely driven by the physician’s assessment of this data, thought process combined with the patient’s history and physical, and presenting conditions and symptoms. Technology like IVUS helps with data-based decisions. I believe we will see increasing interest, clinical focus and development in AI and machine learning software. This will grow not to replace the physician or their judgement, but to augment the increasingly large amount of data, information and decision-making processes facing the physicians and other healthcare personnel caring for patients in the interventional X-ray suite and procedures.

About the author: Tom Watson is principal spend advisor for symplr.