by
Carol Ko, Staff Writer | April 30, 2013
From the April 2013 issue of HealthCare Business News magazine
Because ultrasound microbubbles behave and flow like red blood cells in the body, they enable physicians to assess blood flow in the patient in real time. In other words, instead of waiting for the radiopharmaceutical agent to circulate and absorb into the body, with ultrasound contrast doctors are able to evaluate blood flow at the bedside in a matter of minutes. “I think that’s the holy grail of contrast,” Dr. Vincent L. Sorrell, director of cardiovascular imaging at the University of Kentucky Chandler Medical Center, tells DOTmed Business News.
If approved for myocardial perfusion, this technology would hold several advantages over conventional nuclear imaging: it’s much faster, uses more portable equipment, and has the potential to reduce average lengths of stay at hospitals. The microbubbles are also nontoxic, letting patients avoid radioactive agents — a particularly relevant concern given the heightened public attention around dose and radiation in recent years.
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The fragile supply chain for technetium-99m, the most frequently used radiopharmaceutical agent for myocardial perfusion tests, may also strengthen the case for ultrasound. Three years ago the unexpected shutdown of two out of only five nuclear reactors in the world that produce molybdenum- 99, a key ingredient of tech-99, caused shortages that resulted in delayed testing.
To be sure, ultrasound contrast had its own supply chain troubles in 2012. Due to a prolonged shutdown of Lantheus’ contrast manufacturer, Definity was listed on the FDA Drug Shortages Index. In 2013, Lantheus received FDA approval for a new manufacturing site for its product. “Supplier diversification for our core products is a key priority,” Cyrille Villeneuve, chief commercial officer at Lantheus, tells DOTmed Business News.
All in all, the long-term financial outlook of tech-99 production remains particularly precarious even compared with ultrasound contrast. In February 2012 GE quietly dropped out of a new project to create moly-99, saying it was not commercially viable.
Though ultrasound contrast has not yet received FDA approval for use in myocardial perfusion testing, it’s already used for other kinds of scans. It’s also undergone numerous clinical trials that have shown it to be safe and patient-friendly. Though researchers are still working on refining its use for perfusion, most experts agree that it’s only a matter of time before it’s used in practice. “If ultrasound contrast gets approved for more indications that will certainly add to the market” says Millenium Research Group’s Sharma.
