Press Release Details

N.BILLERICA, Mass. (May 28, 2009) – Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announces that it has completed patient enrollment of CaRES (Contrast Echocardiography REgistry for Safety Surveillance), the first, multicenter Phase IV observational registry that evaluates the use of ultrasound imaging agents in routine clinical practice. The 1,060 patients who were enrolled at 15 sites in the U.S. were 18 years old or older and required DEFINITY® Vial for (Perflutren Lipid Microsphere) injectable suspension-enhanced echocardiography because of a previous suboptimal, unenhanced echocardiogram.

"As the first, multicenter safety registry of its kind to be conducted in the U.S., the results from CaRES will provide important clinical information about the use of DEFINITY® in a range of patient types and clinical settings,” said Mark Hibberd, M.D., senior medical director, Lantheus Medical Imaging, Inc. “We are excited to complete enrollment of this important study and look forward to gaining new insights regarding the use of DEFINITY® in routine clinical practice. We expect these findings to reveal that DEFINITY® is being used in the settings recommended in the recent American Society of Echocardiography Consensus Statement¹, and that these uses are well tolerated. The use of DEFINITY® in appropriate settings, such as in-hospital and intensive care units, can assist physicians in making immediate point-of-care decisions, as recently shown by Kurt et al² and in doing so, can help reduce the use of other more costly tests and direct medical therapy to meet patient needs.”

The CaRES registry was established following discussions with the FDA to further explore the clinical use of DEFINITY®. The prospective, open-label, non-randomized, Phase IV surveillance registry will gather and analyze data on: patient demographics and characteristics, reasons for using DEFINITYÒ, results of safety monitoring, and the nature and frequency of any adverse events.

“Since DEFINITY® received approval for use in the U.S., approximately two million doses have been administered to patients with suboptimal echocardiograms to see the borders of the heart more clearly. Recent articles published in the American Journal of Cardiology³and the Journal of the American College of Cardiology⁴ have highlighted the clinical benefit of DEFINITY® in lowering the risk of short-term mortality and improving diagnostic evaluations for patients receiving contrast-enhanced echocardiograms,” said Don Kiepert, president and CEO of Lantheus Medical Imaging, Inc. “With the completion of enrollment of the CaRES registry, Lantheus continues our ongoing commitment to providing important clinical information on the use of DEFINITY® to the physician community.”

About Suboptimal Echocardiograms
Up to 20 percent of resting echocardiography studies will result in suboptimal echocardiograms.⁵,⁶,⁷ A suboptimal image is one in which at least 2 out of 6 myocardial segments of the left ventricle cannot be visualized appropriately, as defined by the American Society of Echocardiography (ASE).⁸,⁹ The use of contrast in suboptimal echocardiograms may help with clinical evaluation of the patient.¹⁰,¹¹

About DEFINITY®
Since its launch in 2001, activated DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension has been administered to over two million patients.¹² In patients with suboptimal echocardiograms, DEFINITY® enables physicians to visualize the borders of the heart more clearly.¹³,¹⁴

Indications
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established. For full prescribing information, please visit www.lantheus.com.

Important Safety Information About DEFINITY®

Do not administer DEFINITY® to patients with known or suspected cardiac shunts (right-to-left, bi-directional or transient right-to-left), or hypersensitivity to perflutren.  Do not administer DEFINITY® by intra-arterial injection.

In postmarketing use, uncommon but serious reactions observed during or shortly following perflutren-containing microsphere administration included fatal cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or fibrillation), hypotension, respiratory distress or cardiac ischemia (see ADVERSE REACTIONS).  The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation).  In the absence of these underlying conditions, observe patients closely during and following DEFINITY® administration. 

Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY® administration and monitor all patients for acute reactions.