ECHO 2013 / Contrast for Diagnosis and Therapy
.pdfCoronary Recanalization in MI (porcine)
Contrast-Enhanced Sonothrombolysis
Xie, F. et al. Circulation 2009;119:1378 |
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•Barriers to commercial development
–From „99-‟04, Amersham and Schering each spent ~$1B
»0 new products, 0 new indications
–New agents cost >$200M to get through FDA
»Need this much in yearly revenue to be viable
–The more specific the marker, the smaller the market
»The higher the cost: 10,000 cases $20K charge
» Good luck with that!
JACC Img 2011; 4: 799-806 |
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Contrast Shortages
Part of a Larger Problem
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•Ben Venue Laboratories no longer producing Definity (or anything)
•Production moved to Jubilant Hollister Stier
• Optison production moved to Norway
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Conclusions
•Contrast-enhanced ultrasound is critical to diagnostic echocardiography
–Particularly true for stress and dobutamine echo
•ICAEL accreditation requires a contrast policy
•Safety is proven with relatively rare contraindications
•Perfusion is proven but not yet approved or ready for routine use
•Future diagnostic and therapeutic uses incredibly exciting but daunting approval process
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