FDA approves new ultrasound contrast agent
Wed, 01 Aug 2001 23:21:38 | Laurent Castellucci

Wilmington, DE - DuPont Pharmaceuticals announced today they have received FDA approval for their Definity? (Perflutren Lipid Microsphere) ultrasound contrast agent. Definity is used to improve the efficacy of ultrasound by increasing the opacity of the left ventricle in patients with sub-optimal echocardiograms. Definity already has market approval for heart, liver, and kidney imaging in Canada.

Definity is the first ultrasound contrast agent not derived from blood that has received approval for marketing in the US. These "next-generation" ultrasound contrast agents eliminate some of the concerns associated with the use of blood-based products, according to DuPont's press release. Definity should not be administered to patients with cardiac shunts or chronic pulmonary vascular disorders.

The approval of Definity by the FDA was based on multiple clinical trials involving more than 1700 patients at more than 20 medical centers nationwide in which echocardiography done with Definity was more effective at delineating wall motion and the endocardial border when compared to echocardiography done with no contrast agent. DuPont expects to begin selling the product this fall.




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