Developments in Contrast Imaging

A Roundtable with Bracco Diagnostics Inc., Covidien, GE, and Guerbet LLC

EHM speaks to a roundtable of industry experts - Anthony Lombardo of Bracco Diagnostics Inc., Rick Lytle of Covidien, Kathleen Deardorff of GE Healthcare Medical Diagnostics and Melissa Buchanan of Guerbet LLC - about the opportunities and challenges that currently exist in the contrast imaging space.

EHM. With respect to research and development, can you explain how your efforts are currently aligned with the needs of your customer in the imaging space?
Anthony Lombardo. Our customers need, and want, solutions that enable them to get good images; better understand how to treat all patients, particularly those at high risk; maintain and even reduce costs; and manage the entire process smoothly and in a way that is tailored to the individual needs of each patient.

Customers are looking for a partner that can help them deliver the right contrast, for the right procedure, for the right patient, with the right protocol and at the right cost. This is the guide we use to manage our pipeline of products.

Our objective is to tailor our existing products to new technologies while managing our R&D pipeline to respond to future developments in the industry. As an example, we’re carefully watching ultrasound contrast imaging, already being used in Europe, and we’re also watching with great interest the use of biochemically targeted drugs that are just now coming into wide therapeutic use.

Rick Lytle. At Covidien, we design our research and development activities to correlate with the market feedback we receive. Our goal is to meet our customers’ requirements and support their efforts to meet their patients’ needs. In fact, since Covidien’s split from Tyco International in 2007, we have more than doubled our research and development investment in the imaging space.

We are committed to helping clinicians diagnose disease as early as possible with innovative ‘best-in-class’ products and services focusing on cardiology, oncology and delivery systems. Our partnership with customers is the inspiration for product innovations that meet the needs of healthcare professionals and patients.

Kathleen Deardorff. Our R&D efforts must support the daily clinical decisions that are made by physicians and not just individual products. To that extent, we have a rigorous process that drives our R&D program from close contact with key luminaries in various therapeutic disciplines to the types of imaging procedures completed and challenges that are trying to be solved. This foundation has GE focused on three main areas: cardiology, oncology and neurology. It also has put us at the forefront of the evolution of imaging from a ‘one size fits all approach’ to an ‘individual need’ as we increase investment in the future of molecular imaging as well.

Melissa Buchanan. Guerbet invests nine percent of sales and 160 employees into research and development, focusing on cardiovascular disease, oncology and inflammatory/neurodegenerative conditions. These efforts and our work with a worldwide network of scientific partners, allow us to bring high-quality product solutions to customers across the globe.

Guerbet’s offering in the US includes Oxilan (ioxilan injection) and Hexabrix (sodium and meglumine ioxaglate), two low-osmolar and low viscous imaging agents, which provide patient comfort, visibility and safety. We anticipate exciting new data on the renal safety of both products in 2009.

First, Dr. Per Liss shared preliminary information at RSNA 2008 confirming the renal safety of Hexabrix within one year after injection. In addition, we look forward to the American Journal of Cardiology June 2009 publication of registry data compiled by Dr. Refat Jabara at St. Joseph’s Research Institute. These data address renal safety and support Oxilan as an effective and safe contrast media.

EHM. What are the most critical factors, as your company identifies them, that you feel need to be communicated, integrated and executed at the clinical level from a medical diagnostics perspective?
AL. One critical factor is the efficacy and safety of contrast media, especially in the wake of media coverage of contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF). We’re already conducting clinical studies, and we will share the results so medical professionals can better inform patients and improve their practice.

We’re seeking to place relevant, life-saving data at clinicians’ fingertips, whether through innovative web platforms or making protocols available on advanced delivery systems.

We also offer a robust portfolio of educational offerings. In fact, many of these educational offerings help physicians, technologists and nurses fulfill their continuing medical education (CME) requirements.

Another important factor is helping customers better understand how to manage high-risk patients. As the US population ages, radiologists will see an increasing number of high-risk patients in the over-65 age group. They’ll need to understand these risks and how to address them.

The reality of the current reimbursement situation also creates challenges for radiologists as they seek to increase workflow and throughput while also focusing on providing patients with quality healthcare. We’re helping customers deal with the financial realities of reduced reimbursements.

RL. Risk reduction is one of the key challenges facing the radiology community. As the number of CT procedures performed each year continues to rise, so does the potential for medication errors in radiology departments. Advancements in injector and integrated delivery system technologies can help address the concern for medication errors and patient safety within the hospital setting.

At Covidien, we continuously work toward solutions designed to help enhance patient safety, reduce medication errors, prevent infection and increase efficiency. For example, our RFID-enabled system (the Optivantage dual head CT contrast delivery system combined with the Ultraject prefilled syringes and RFID technology) creates an intelligent interface between the contrast media syringe and the power injector. This, when both components are RFID-enabled, helps radiology technologists ensure that each patient receives the prescribed concentration and programmed dose of a contrast media-related drug during a procedure.

When properly used, this system helps safeguard against certain life-threatening medication errors, prevents accidental air embolism from using an empty, used syringe and prevents accidental patient cross-contamination from using a partially used syringe in another patient exam.

In addition, the concern over meeting quality standards in radiology is ever growing. We are committed to helping radiology departments comply with standards set by the Joint Commission, an independent, not-for-profit organization that certifies more than 15,000 healthcare organizations and programs in the United States. Using Covidien’s prefilled syringes helps radiology departments meet the requirement to use the most ready-to-administer product, reducing the need for hand labeling compared with that for manually filled syringes and decreasing the number of steps necessary for compliance with these national patient safety guidelines.

KD. Things move fast and decisions must be made quickly. Communicating outcomes data is vital, but the complex nature of clinical trials, data, evidence-based medicine and clinical experience cannot be summed up in five-minute sound bites. We believe that understanding what goes into a clinical trial, how there are differences in structure and results and what can be taken away from trials in the name of patient management is vital. Communicating this and how our products fit into overall clinical practice is essential.

MB. Guerbet believes strongly that the choice of contrast media has an important impact on patient outcomes. The discussion of contrast media has centered on a product’s osmolality, which is an important factor, but certainly not the only factor. Research by Dr. Richard Solomon in the CARE study suggests that when comparing iso-osmolar contrast media with low osmolar contrast, “Any true difference between the agents (in terms of the rate of contrast-induced nephropathy) is small and not likely clinically significant.”

We are working with leading industry physicians to demonstrate that the viscosity of the contrast media is also an important property, which must be considered. Dr. Michele Voeltz coined a new contrast media classification distinguishing low viscosity contrast media (LVCM) from high (HVCM) in her article published in the Journal of Invasive Cardiology, which highlights the important role that viscosity can play. Guerbet is proud to offer two contrast media products, Oxilan and Hexabrix, which provide a balance of low viscosity and low osmolality.

In addition to this balance, Hexabrix also provides the unique anti-coagulant properties of a low osmolar ionic contrast media, as demonstrated in several clinical and in vitro studies such as those by Grines et al (JACC 1996) and Le Feuvre et al (Catheter Cardiovasc Interv 2006). With the increasing focus on prevention of thrombotic events, we hope to help make physicians aware that Hexabrix is the only proven option, which provides an added layer of protection for their patients. 

EHM. What are the main challenges facing the contrast imaging business in the short term, and how are you addressing these challenges?
AL. Clearly, many clinicians’ concerns now revolve around the Deficit Reduction Act (DRA) and the incorrect perception that imaging is an overused and often unnecessary medical procedure.

In 2008 alone, there was a projected loss of $1.2 billion in Medicare technical payments due to DRA, and $1 billion due to the CMS contiguous body part reductions. Bracco is one of many companies that remain steadfast in activities that combat the perceptions and fight for reimbursement policies that reflect the reality of healthcare today and better serve the patients who place their trust in caregivers.

How does Bracco enable its customers? We do this using a three-pronged approach:
1. Solutions in contrast: We provide a variety of products/sizes that are tailored to customer needs in MRI, CT, oral imaging and upcoming uses such as    dysphagia, and integrate them with delivery systems
2. Science: We back up this portfolio with valuable clinical evidence to address the issues, old and new, that are facing our customers
3. Services: We provide our products along with the science behind the products through an articulated system of well-trained sales consultants, clinical specialists and medical professionals.

RL. Economic pressures are challenging businesses, industries and most importantly, our customers, throughout the world. Covidien is committed to helping our customers manage through these challenges by maintaining its focus on delivering innovative and cost-effective clinical and economic healthcare solutions, which help to both enhance the quality of life for patients and improve outcomes for our customers and our shareholders.

KD. There is no question that imaging, particularly in well-developed markets such as the US, is undergoing a scrutiny unlike anything we have witnessed in prior cycles. One of the main challenges, and opportunities, is to work together – manufacturer, hospital, society, and government – to not only identify the vital role that imaging has in today’s patient management but also the vision that it provides for the future in terms of aiding the prevention of disease earlier and managing it earlier, both significantly improving outcomes and ultimately overall healthcare costs.

There also is a tendency to be focused on cost for the sake of cost alone. These are pharmaceutical products that are used on people every second of the day – we must make sure we never forget that, and understand patients for the individuals they are and identify the best overall imaging solution for them.

MB. For the next 12 to 18 months the contrast imaging business is facing challenges very similar to that of the medical industry as a whole. Increasing economic pressures, such as reduced Medicare/Medicaid reimbursements, are forcing our country’s hospitals, imaging centers and clinics to make difficult cost-cutting decisions. We see increased consolidation in the industry across all players, including healthcare providers, group purchasing organizations and imaging companies.

At Guerbet, we address these challenges by furthering our expertise as an imaging specialist company and investing in our customer relationships. This commitment to our customers allows us to be a true partner; we can then work together to find solutions to these challenges.

EHM. Taking into consideration technology and paradigm shifts, patient profiles and new compounds – what are the main challenges facing the contrast imaging business in the next two to five years, and how are you preparing to address these challenges?
AL. There are increasing calls for healthcare reform in the United States and other countries. As the Obama administration begins to shape its healthcare agenda, the two themes that have emerged thus far are preventing errors and using technology to improve and co-ordinate care. What better way to prevent errors than to have an accurate diagnosis in the first place? The imaging industry will have an increased and important role to play in that regard. But we also must make certain that we fully communicate the safety and efficacy of contrast imaging solutions. That means continuing our research and clinical studies. We also need to work together with the device manufacturers so that we can supply clinicians with what they need to optimize imaging procedures.

RL. Continuing to provide innovations to customers that bring value and help to improve the diagnosis of disease will be a challenge for the industry over the next few years. To do this, we need to engage in activities that drive a culture of quality and compliance. As a pioneer and innovator, Covidien will foster growth in our research and development pipeline to bring forth new technologies that advance insight for customers every day, providing critical knowledge and furthering their understanding of each case, to help them make insightful diagnoses.

We will continue to provide the products needed to assist practitioners in the early diagnosis and treatment of disease to deliver better patient outcomes and improve lives.

KD. We must consistently remind ourselves and all affected parties of the importance of imaging on the patient, and the only way to do this is to have an open, honest dialogue about imaging, agents, safety, appropriateness and working together to deliver healthcare in a more efficient manner.

New procedures and diagnostics will provide improved healthcare and be sought after and it is important to work collaboratively to allow this to occur in a way that keeps the patient in mind.

MB. I would say that there are more opportunities than challenges facing the contrast imaging business in the next two to five years. Magnetic resonance (MR) procedures are growing, which is fuelling growth in the MR contrast media market. This growth, however, is somewhat tempered by the rising concern over nephrogenic systemic fibrosis (NSF). Guerbet is currently conducting clinical trials in order to bring an MR product to the US.

Although the X-ray contrast media market is somewhat more mature, we continue to expect modest but stable growth. Emerging technologies such as drug eluting stents and increasing use of computed tomography angiography (CTA) are driving the conversations among industry leaders, and contrast selection can play an important complementing role. Guerbet is focused on being a resource partner for our customers; supplying them with specialist product knowledge and contributing to their long-term success.

Anthony A. Lombardo is Chief Operating Officer of Bracco Diagnostics Inc., and has been involved in the diagnostic imaging industry for nearly 25 years. In his role at Bracco, Lombardo leverages his extensive experience running global business units in the healthcare industry and his intimate understanding of both domestic and international operations.

Richard A. Lytle is Vice President and General Manager, Imaging Solutions, Covidien. He is responsible for directing the US sales, marketing, pharmacy operations, sales training and distribution functions for the Imaging Solutions Division of Covidien. The Imaging Solutions Division is a leading manufacturer of contrast media, delivery systems and nuclear medicine products and services.

Kathleen P. Deardorff has held several strategic marketing leadership roles in GE’s Medical Diagnostics business. Presently, she is the head of the Global Marketing Organization and Product Acquisition and Licensing. Kathleen is responsible for providing leadership and marketing direction for the Medical Diagnostics team, building on its heritage of a strong marketing focused organization. Kathleen is also a member of the Medical Diagnostics Executive Committee.

Melissa Buchanan is Associate Brand Manager at Guerbet LLC. Buchanan has an undergraduate degree in Business Operations through the Kelley School of Business at Indiana University, and earned her Master of Business Administration from Butler University in 2008. She has worked in the pharmaceutical industry for the past seven years.