Currently, the standard diagnostic tool for cardiovascular disease is X-ray angiography, a procedure that involves inserting a catheter into the arteries to deliver the X-ray dye. An estimated 3.3 million diagnostic X-ray angiograms are performed annually in the United States alone at a total cost to the health care system of over $6 billion. Atherosclerosis is the major cause of death and a primary concern for health care providers all over the world. AngioMARK, the intravascular MRI contrast agent, developed by EPIX and Mallinckrodt, is now in a pivotal Phase III trial to determine its efficacy for detecting aortoiliac occlusive disease in patients with known or suspected peripheral vascular disease or abdominal aortic aneurysm.
William Loeffler, Vice President of MR Applications Development at Siemens Medical Systems believes that computer-based visualization is the future of diagnostic medicine. Siemens is committed to developing next-generation medical imaging technologies that are able to harness this potential through the use of contrast agents such as AngioMARK, William Loeffler continues. By optimizing the MRI scanning protocols for use with a contrast agent, the company will ensure that the entire system works cohesively. This will both improve clinical utility of new products and reduce commercial risks.
In turn, Michael D. Webb, the EPIX Medical President and Chief Executive Officer, states that this collaboration will result in the design of valuable visualization tools. According to his expectation, these new technologies are able to drive the widespread clinical use of AngioMARK-enhanced MRI into new areas of diagnostic medicine. Finally, Bradley J. Fercho, President of Mallinckrodt's Imaging Group, confirms that as a global leader in imaging agents, it is his company's priority to provide physicians with tools to help them diagnose and manage cardiovascular disease. The partnership with EPIX and Siemens will enable Mallinckrodt to offer this innovative, non-invasive imaging system to improve the diagnostic pathway for patients and their doctors.
Under the non-exclusive collaboration, the three companies will combine resources to optimize imaging technology and improve the visualization of arteries and veins in patients undergoing magnetic resonance angiography (MRA). The partnership draws on Siemens' substantial expertise in MR scanning and visualization technologies as well as the unique properties of AngioMARK, the intravascular contrast agent being jointly developed by EPIX and Mallinckrodt. The collaboration will also focus on expanding the use of MRI in diagnosing cardiovascular disease and providing user-friendly tools for easy visualization of the cardiovascular system in the 3D space. Research and development will be carried out at Iselin, New Jersey, and Cambridge, Massachusetts.
AngioMARK is an investigational new drug designed to enhance MR imaging of the cardiovascular system. EPIX and Mallinckrodt announced in June the commencement of a Phase III efficacy trial for use of AngioMARK MRA, as to detect aortoiliac occlusive disease. The trial, a multi-centre, two-arm study, is designed to compare the diagnostic accuracy of AngioMARK-enhanced MRI with that of X-ray angiography, the current standard for diagnosing vascular disease.
Siemens Medical Systems Inc., headquartered in Iselin, provides medical solutions across a broad range of United States clinical environments. The company develops and manufactures advanced diagnostic, therapeutic and monitoring equipment, imaging systems and consulting services. Employing nearly 4500 people in the U.S., and reporting annual sales of approximately $1.7 billion, it is the U.S. affiliate of the Medical Engineering Group within Siemens AG, with divisional headquarters in Erlangen, Germany. Worldwide, Siemens Medical Engineering employs approximately 23.000 people and has annual sales of some $5 billion.
Mallinckrodt Inc. is a worldwide manufacturer and marketer of speciality health care products for respiratory care, diagnostic imaging, and also pain management. The company's imaging group provides contrast agents for magnetic resonance imaging, x-ray, and ultrasound for imaging a wide range of diseases. Mallinckrodt operates in more than 100 countries globally and had fiscal 1999 net sales of $2.6 billion.
EPIX Medical, based in Cambridge, Massachusetts, is developing targeted contrast agents to improve the capability of MRI as a diagnostic tool for a variety of diseases. The company's principal product under development, AngioMARK, is an investigational new drug. In addition to the ongoing Phase III clinical trials for aortoiliac occlusive disease, AngioMARK is currently in Phase II feasibility trials for coronary artery disease as well as breast cancer. More news about EPIX' activities is available in the VMW article EPIX Medical's new multimedia Web site features AngioMARK images in 3D.