Interventional X-ray Radiation Dose Reduction in the Market

In the past few years, there has been an increasing focus on cumulative radiation dose exposure, effects and guidelines in the medical field and, in particular, in the CT and interventional X-ray markets. Manufacturers have always focused on dose reduction and control, but the publicity and regulations have evolved, and the associated publicity and public awareness and focus have pushed them to even higher priority.

Vendor Offerings for Dose Reductions Continue to Evolve

This has spurred development and new technology release from most vendors, which, not surprisingly, often comes with an additional price tag. This is exemplified by Philips’ AlluraClarity and Siemens’ Artis Q and Artis Q.zen technology releases. Each respective vendor continues to offer the Allura Xper and Artis zee series, which are still staples of the product line, but don’t include some of the highly touted dose-reduction solutions that maintain image quality while reducing dose. GE Healthcare and Toshiba, two additional vendors, also provide active and aggressive programs for dose management and reduction but have yet to release formal product lines to incorporate a “new level” of dose management that they want to brand with a new solution name.

Vendors are actively incorporating their dose reduction and management solutions into their marketing and competitive presentations. These advancements continue to be debated in terms of which is “best” or “better.” The dose management reduction issue is extremely complex and related to many more variables than what the vendors have done to improve their technology.

However, there are a number of other solutions that have worked to capitalize on the radiation dose reduction initiative and awareness, as well. We will briefly discuss a few of the more high-profile solutions MD Buyline customers are interest in with regards to this area, particularly focused on the medical staff.

Radiation Shielding

Radiation ShieldingThis has been the traditional method for minimizing dose exposure with heavy lead aprons, thyroid collars, eyewear for personal protection and strategically placed barriers mounted to the table or on ceiling suspended articulated arms to provide an additional lead barrier to radiation beams and scatter.
With regard to the personal protection, CFI Medical has created Zero Gravity for the physician. This full head-to-ankle protection solution is designed to provide protection to the operator in a single complete unit and protects the sterile field. It is mounted to the ceiling, which alleviates the debilitating effects of lead aprons worn for hours on end for interventional physicians.

Users say it works but takes some getting used because it can feel more restrictive than they are used to. However, once they are used to it they find it works quite well. MD Buyline quote activity suggests this is a solution that is not yet widely accepted. The purchase price range that runs from about $75,000 to $85,000 per unit may be one of the hurdles this concept must overcome.

Robotics

Robotic technology has already become an established surgical technique for endoscopic and other surgeries with the DaVinci system from Intuitive Surgical. Several companies are using the robotic concept to address dose reduction and exposure for the operator, as well.

UntitledCorindus Vascular Robotics offers the CorPath, which allows an interventional physician the ability to position, advance and control an angiography catheter remotely while sitting at a workstation. Physicians traditionally position and manipulate the catheter at the table side with manual manipulation by using the joystick and control panel.

This technology requires not only the computer, console and remote catheter device, but also proprietary catheter cassettes to hold and manipulate the catheter. This has also met with limited success, and most interest comes from large university and teaching institutions. The price for this technology is in the $225,000 to $250,000 range for the capital equipment with $600 to $700 in per case consumable supplies.

Hansen Medical offers the Sensei Robotic Catheter System (cardiac) and the Magellan Robotic Catheter System (vascular). This vendor uses the remote robotic catheter control, as well.
Hansen has been around longer than Corindus and Hansen was one of the first to introduce robotic catheter control in about 2009. The concept of robotic catheter control initially generated a fair amount of interest. They expanded their product line with the introduction of the Magellan, which is targeted more to vascular applications. This system also has met with limited interest, much like the CorPath from Corindus. I believe a key reason for this is robotic systems require both capital and proprietary purchase. The Magellan is in the $600,000 to $700,000 range for capital. The Sensei is in the $450,000 to $550,000 range for capital. The cost of proprietary consumables adds to the procedure expense, but does not result in any additional reimbursement.

St. Jude MediGuideSt. Jude Medical acquired MediGuide, a unique solution that uses GPS tracking to conceptually provide the ability to move and position catheters based on significantly reduced need for live radiographic guidance. This can allow catheter movement and positioning without generating any dose exposure after a radiographic image is captured and coordinated with the MediGuide GPS system. This is a more recent concept system that requires a capital outlay in excess of $1,000,000 along with proprietary catheter technology. Additionally, this requires a level of integration with the X-ray imaging system that limits the choices of vendor and models of X-ray systems. Primarily, we have seen this only quoted with special configuration of Siemens’ Artis zee systems.

Financial Concerns Restrict Adoption of Certain Dose-Management Systems

There are a number of additional solutions to assist in reducing the dose exposure, mostly of the physician and staff that work in this environment. However, they are all experiencing limited success in terms of widespread acceptance based on the quote activity seen by MD Buyline. We believe the common denominator is financial. These are all relatively expensive adjunctive solutions, ranging from $75,000 to over $1,000,000. Many of these also require expensive, proprietary per case consumables. None of these result in any additional reimbursement for the procedure. As a result, the return on investment is not affected by the actual payments the hospitals receive for their use. It can be debated that the benefit exists in terms of a reduction of radiation exposure to physicians and staff and, in some cases, the patient. However, the fact remains it is a substantial expense that has no direct or easily measured return on investment.

Until there are definitive and measurable metrics that can justify the cost or until the cost of both capital and consumable expense decreases substantially, these solutions will remain of interest mostly to high-end university and teaching institutions rather than a mainstream solution for all healthcare providers.

Tom Watson, BS, RCVT
ABOUT THIS EXPERT
Tom Watson, BS, RCVT, Clinical Analyst — Mr. Watson joined MD Buyline in 1986 and has over 40 years of experience in the field of cardiovascular medicine. At MD Buyline, Mr. Watson's primary responsibility is invasive cardiovascular technology - interventional angiography, electrophysiology imaging and monitoring, cardiology PACS and information systems and a number of other areas. He graduated with a Bachelor of Science degree from Louisiana State University. He received registries in both noninvasive and invasive cardiovascular modalities through the National Society of Cardiopulmonary Technologies, as well as adult echocardiography through the American Registry of Diagnostic Medical Sonographers.