May 28, 2009 - Lantheus Medical Imaging Inc. has completed patient enrollment of CaRES (Contrast Echocardiography REgistry for Safety Surveillance), the first, multicenter Phase IV observational registry that evaluates the use of ultrasound imaging agents in routine clinical practice. The 1,060 patients who were enrolled at 15 sites in the U.S. were 18 years old or older and required DEFINITY Vial for (Perflutren Lipid Microsphere) injectable suspension-enhanced echocardiography because of a previous suboptimal, unenhanced echocardiogram.
"As the first, multicenter safety registry of its kind to be conducted in the U.S., the results from CaRES will provide important clinical information about the use of DEFINITY in a range of patient types and clinical settings,” said Mark Hibberd, M.D., senior medical director, Lantheus Medical Imaging, Inc. “We expect these findings to reveal that DEFINITY is being used in the settings recommended in the recent American Society of Echocardiography Consensus Statement[i], and that these uses are well tolerated. The use of DEFINITY in appropriate settings, such as in-hospital and intensive care units, can assist physicians in making immediate point-of-care decisions, as recently shown by Kurt et al[ii] and in doing so, can help reduce the use of other more costly tests and direct medical therapy to meet patient needs.”
The CaRES registry was established following discussions with the FDA to further explore the clinical use of DEFINITY. The prospective, open-label, non-randomized, Phase IV surveillance registry will gather and analyze data on: patient demographics and characteristics, reasons for using DEFINITYÒ, results of safety monitoring, and the nature and frequency of any adverse events.
[i] Mulvagh SL et al. American Society of Echocardiography consensus statement on the clinical applications of ultrasonic contrast agents in echocardiography. J Am Soc Echocardiogr. 2008; vol. 21 no. 11: 1179-1201
[ii] Kurt M et al. Impact of contrast echocardiography on evaluation of ventricular function and clinical management in a large prospect cohort. J Am Coll Cardiol. 2009; 53: 802-810
For more information: www.lantheus.com