Myocardial Perfusion Imaging in the Pediatric Population Peter Gardiner, MB ChB, MRCP Vice President, Medical Sciences Bristol-Myers Squibb Medical Imaging

A worldwide leader in cardiovascular imaging research Product line includes: –Cardiolite ® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) –Definity ® (Vial for Perflutren Lipid Microsphere Injectable Suspension) Committed to appropriate evaluation of imaging drugs and cardiac imaging procedures in children Focus on nuclear myocardial perfusion imaging (MPI)

Nuclear Myocardial Perfusion Imaging Only modality approved by FDA for assessment of myocardial perfusion and function >13 years experience with Tc99m agents Indications: Perfusion; function; exercise and pharmacologic stress Extensive literature documenting use in diagnosis, prognosis and risk stratification Safe and well tolerated Continued growth in usage

Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) Launched in US in 1991 Indications: myocardial perfusion and function; exercise and pharmacologic stress; developing information for use in patient management decisions Leadership position: –Clinical use –Continued significant investment in Clinical Research and Education

Nuclear Myocardial Perfusion Imaging in Children Lack of substantial, well-controlled clinical studies to define dosing and efficacy Usage - ~ 2-3,000 studies in 2002 Patient populations: –Kawasaki’s Disease –Cardiac transplant vasculopathy –Cardiomyopathies (including hypertrophic and drug- induced) –Congenital heart disease, including anomalous LCA

Nuclear Myocardial Perfusion Imaging in Children Advantages –Extensive experience and FDA approved for use in adults –Operator independent –Reduced dose and duration of imaging with Tc99m based agents Disadvantages –Radiation exposure –Limited information on dosing (only weight-based) –Lack of substantial efficacy data

Nuclear Myocardial Perfusion Imaging in Children Summary Nuclear imaging is the only modality approved by FDA for assessment of myocardial perfusion and function in adults Extensive experience in adults Limited and variable experience in children Bristol-Myers Squibb Medical Imaging (BMS MI) supports FDA’s initiatives to evaluate nuclear cardiac imaging in children