Mallinckrodt and MBI file PMA for FS069

November 6, 1996

Mallinckrodt Medical and Molecular Biosystems have filed a premarketapproval (PMA) application for cardiac uses of MBI's second-generationFS069 ultrasound contrast agent. The companies said the PMA coversclinical studies in which FS069 was used for

Mallinckrodt Medical and Molecular Biosystems have filed a premarketapproval (PMA) application for cardiac uses of MBI's second-generationFS069 ultrasound contrast agent. The companies said the PMA coversclinical studies in which FS069 was used for enhancing endocardialborder delineation, as well as opacification of the left ventricularchamber. Doppler signal enhancement was also studied.

San Diego-based MBI is developing FS069 and has granted licensingrights for the agent to Mallinckrodt of St. Louis for North andSouth America, China, Australia, and New Zealand (SCAN 9/13/95).Both parties are hoping the agent will prove more successful thanAlbunex, MBI's first-generation agent, which has received a tepidresponse from the ultrasound community since it was introducedin 1994. Mallinckrodt also markets Albunex.

A phase III clinical trial conducted for FS069's PMA comparedthe agent with Albunex, and demonstrated the newer agent's superiorityin providing endocardial border delineation as well as left ventricularcontrast enhancement, both of which improve visualization of cardiac-wallmotion and function.