Conclusions

The data reviewed above show that MYOVIEW^TM (tetrofosmin) is a true perfusion agent that produces similar diagnostic information to the current gold standard, TI-201. The heart uptake of Tc-99m-tetrofosmin is rapid and retention good. In contrast, lung, liver, blood, and plasma clearance are all rapid. MYOVIEW does not product any pharmacological effects when used at the recommended dose, and there is no evidence of clinically significant drug-related adverse events or drug interactions.

Diagnostic quality images of the heart can be obtained from 15 minutes up to at least 4 hours post-injection. Administration of two MYOVIEW injections (stress and rest) allows for the evaluation of defect reversibility, yet provides flexible scheduling of imaging times. This has important implications in busy nuclear medicine departments, where flexible, efficient camera use and maximum patient throughput are essential. In addition, the preparation of reconstituted MYOVIEW involves no boiling step, an advantage that minimizes radiation exposure for hospital personnel and shortens preparation time.

Carefully controlled worldwide clinical trials have demonstrated that MYOVIEW-derived images provide diagnostic accuracy equivalent to TI-201 in the same patient, using both planar and SPECT methodologies. The data also clearly show that MYOVIEW is useful as an adjunct in the diagnosis and localization of myocardial ischemia and/ or infarction. In conclusion, MYOVIEW has been shown to be a safe and clinically relevant diagnostic radiopharmaceutical for the study of ischemic heart disease.

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