Mallinckrodt's Optimark Imaging Agent Completes Phase II Testing For Myocardial Infarction Indication
ORLANDO, FL - Mallinckrodt, a business unit of Tyco Healthcare, today announced the successful completion of two Phase II studies using OptiMARK® imaging agent to determine safety and effectiveness in identifying the presence, location and extent of myocardial infarctions (heart attacks). The results of these first, large, multi-center, international trials were presented yesterday in abstract form at the American College of Cardiology's 2005 Annual Scientific Session. The data from these dose-ranging studies identified the optimal dose to use in patients with a suspected heart attack and also demonstrated the safety of OptiMARK in this patient population.
"Mallinckrodt has made a considerable investment in new indications for OptiMARK imaging agent, which demonstrates our commitment to the product and the continued growth potential of Magnetic Resonance Imaging," said Steve Hanley, president of the Mallinckrodt Imaging Division. "As we approach the Phase III trials of OptiMARK, we are hopeful that this will lead to a paradigm shift in the diagnosis of myocardial infarction."
The Phase II studies involved more than 600 patients and 26 investigators at 23 international medical centers.
Myocardial infarction (MI) is the death of heart muscle that has been deprived of oxygen due to coronary artery disease. Approximately 1.5 million cases of MI occur each year in the United States. Cardiovascular disease, which includes MI, is the leading cause of death in the United States, accounting for 500,000 to 700,000 deaths each year.
Following a myocardial infarction, the identification of damaged myocardium plays an important role in the management of patients with coronary artery disease. Noninvasive techniques used to identify viable myocardium include echocardiography, thallium nuclear imaging and FDG PET imaging. Although used clinically, these imaging methods possess several limitations such as poor imaging windows, attenuation artifacts causing blurred images, lack of sufficient resolution and lack of ready access.
Magnetic Resonance Imaging (MRI) is able to detect the difference between living heart tissue and tissue that has died or become scarred as a result of a heart attack. The use of gadolinium-based contrast agents enhances areas of non-viable or scarred tissue according to published literature.
Currently, the U.S. Food and Drug Administration (FDA) has approved OptiMARK imaging agent for use in diagnosing abnormally functioning blood vessels and tissues in the brain, spine and liver.
Mallinckrodt, a business unit of Tyco Healthcare, is a global manufacturer and distributor of specialty medical products designed to sustain breathing, diagnose disease, and relieve pain. The company is an industry leader in respiratory care, bulk narcotics and other drug chemicals, and diagnostic imaging. The Mallinckrodt Imaging Division maintains leadership positions in contrast agents and radiopharmaceuticals, including brand names such as OPTIRAY® and OptiMARK®.
Tyco International Ltd. is a global, diversified company that provides vital products and services to customers in five business segments: Fire & Security, Electronics, Healthcare, Engineered Products & Services, and Plastics & Adhesives. With 2004 revenue of $40 billion, Tyco employs approximately 260,000 people worldwide. More information on Tyco can be found at www.tyco.com.
Source: Mallinckrodt