Lantheus Holdings has secured the US Food and Drug Administration (FDA) supplemental new drug application (sNDA) approval for VIALMIXRFID device, for use with DEFINITY Vial.
The medical equipment maker said that its VIALMIXRFID is a next generation activation device, designed to activate DEFINITY, an injectable ultrasound enhancement agent used in patients with suboptimal echocardiograms, and comprises perflutren lipid microspheres.
Available in a liquid-filled glass vial, DEFINITY needs to be activated before the use, to create the lipid-encapsulated microbubbles. VIALMIXRFID activates the ultrasound enhancing agent using an RFID tag, which is attached to the label of the DEFINITY vial.
VIALMIXRFID leverages radio-frequency identification technology to activate DEFINITY
Lantheus said that its VIALMIXRFID leverages radio-frequency identification technology to control the activation rate and time during the activation of DEFINITY.
The company has secured the US patent for the use of its new VIALMIXRFID activation device with validity up to 2037, and has been listed in the Orange Book. The company has also filed additional patent applications in key markets across the world.
Lantheus is engaged in developing, manufacturing and commercialisation of advanced diagnostic and therapeutic products, through its subsidiaries Lantheus Medical Imaging, Progenics Pharmaceuticals.
The company also offers TechneLite, a technetium-based generator that provides medical isotope for nuclear medicine procedures, AZEDRA to treat rare neuroendocrine tumors, and RELISTOR for opioid-induced constipation.
Lantheus president and chief executive officer Mary Anne Heino said: “The approval of VIALMIXRFID further strengthens and extends our core microbubble franchise. By controlling the activation rate and time, the RFID technology ensures reproducible activation of DEFINITY and reduces risks related to operator or medication errors, potentially increasing patient safety.
“Importantly, VIALMIXRFID has been designed to work with our currently approved DEFINITY vial and our DEFINITY modified formulation product candidate. I am grateful to the entire Lantheus team that worked tirelessly to bring this next generation activation device to the market.”
