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FDA approves label change for ultrasound contrast agent

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Lantheus Medical Imaging Inc. announced that the FDA has approved a label update that removes the contraindication statement related to use in patients with a known or suspected cardiac shunt from the U.S. prescribing information for an ultrasound contrast agent.

Perflutren lipid microsphere (Definity, Lantheus Medical Imaging) injectable suspension is indicated for use in patients with poor echocardiograms to opacify the left ventricular chamber and enhance the delineation of LV endocardial border, according to a press release.

“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of Definity, which has been used to perform more than 7 million echocardiography studies,” Cesare Orlandi, chief medical officer at Lantheus, said in the release. “The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to Definity when undergoing cardiac ultrasound imaging.”

Up to 35% of patients who presented with a cardiac shunt had previously been excluded for receiving an echo contrast study of the LV. The removal of the contraindication was based on a submission from Lantheus citing a number of publications and data that supported the safety of echocardiography contrast products in patients with cardiac shunts, according to the release.

“This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes,” Neil Weissman, MD, president of MedStar Health Research Institute in Washington, D.C., said in the release.

Disclosure: Orlandi is an employee of Lantheus. Weissman reports receiving grants from Abbott Vascular, Boston Scientific, Direct Flow Medical, Edwards Lifescience, JenaValve, Medtronic and Sorin.