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Bristol-Myers Squibb Medical Imaging Receives European Commission Marketing Authorisation for Its Ultrasound Contrast Agent LUMINITY(TM) (perflutren lipid microsphere)
N. Billerica, Massachusetts (ots/PRNewswire) -
Bristol-Myers Squibb Medical Imaging announced today that the European Commission has granted marketing authorisation for LUMINITY(TM), an ultrasound contrast agent, for use in patients with suboptimal echocardiograms who have suspected or established coronary artery disease.(1)
"With LUMINITY, health care providers in Europe have a new and effective option to improve the utility of echocardiography, the most widely used cardiac imaging modality," said Tim Ravenscroft, president, Bristol-Myers Squibb Medical Imaging. "This approval represents another important milestone in our company's continuing commitment to advance cardiovascular imaging for patients around the world."
Echocardiography with contrast enhancement is recommended by the British and American Societies of Echocardiography as a method of improving the diagnostic accuracy of suboptimal echocardiograms.(2,3) In the USA, it is estimated that up to 20 percent of all routine echocardiograms are suboptimal.(2)
LUMINITY(TM) opacifies the left ventricular chamber and improves the delineation of the left endocardial border during both rest and stress echocardiography.(1) In a recent study of stress echocardiography, where the resting images were difficult-to-interpret, 95 percent of the LUMINITY(TM) enhanced images were diagnostic compared to 66 percent of the unenhanced images.(4) In these patients, LUMINITY(TM) significantly reduced the need for subsequent testing.(4)
"LUMINITY has been shown to enhance the yield of diagnostic images both at rest and during stress echocardiography," said Dr. R. Senior, director of Cardiac Research at Northwick Park Hospital, Harrow, UK. "LUMINITY will expand the use of contrast in cardiology."
LUMINITY(TM) has been approved with no cardiovascular contraindications. It has been administered in more than one million patients worldwide and is approved for use in 10 other countries including Canada and the USA, where it is marketed as DEFINITY(R).
About Bristol-Myers Squibb Medical Imaging
Bristol-Myers Squibb Medical Imaging is a worldwide leader in cardiovascular imaging whose mission is to extend and enhance human life by offering innovative approaches to see deeper into the heart and vasculature. Bristol-Myers Squibb Medical Imaging is a wholly-owned subsidiary of Bristol-Myers Squibb Company (NYSE: BMY), a pharmaceutical and related health care products company. Bristol-Myers Squibb Medical Imaging's European operations is based in the UK and is a division of Bristol-Myers Squibb Pharmaceuticals Ltd.
(1) LUMINITY(TM) SPC. September 2006.
(2) Waggoner AD et al. J Am Soc Echocardiography 2001; 14(5): 417-429.
(3) British Society of Echocardiography Policy Committee. Heart 2004:
90(Suppl V): vi23-vi30.
(4) Weiss RJ et al. J Am Soc Echocardiol 2005: 18(5): Abstract P1-03.@@end@@
LUMINITY(TM) is a trademark of Bristol-Myers Squibb Medical Imaging, Inc.
DEFINITY(R) is a registered trademark of Bristol-Myers Squibb Medical Imaging, Inc.
Web site: http://www.bms.com
ots Originaltext: Bristol-Myers Squibb Medical Imaging
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