Bracco Diagnostics, the US subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, has announced the US Food and Drug Administration (FDA) approved Varibar Pudding for Modified Barium Swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients six months and older.
Oropharyngeal impairment is a frequent cause of morbidity and disability in all age groups, resulting from congenital abnormalities or a wide spectrum of neurologic causes for impaired swallowing, including cerebrovascular accidents (stroke, the most common cause of swallowing disorders in adults), tumors, motor neuron disease, demyelinating diseases, connective tissue diseases, metabolic disorders, and infections. Accurate and reliable measures of oropharyngeal swallowing function are key to proper patient management and improved outcomes. Radiographic (x-ray) modified barium swallow (MBS) studies are the instrumental examinations of choice because they allow evaluation of both the oral and pharyngeal phases of swallowing, and are key to determine the nature and extent of the swallowing disorder.
“Before the approval of Varibar Pudding, no barium products were approved for use in MBS exams, nor validated prescribing information aiming at guaranteeing optimal and reproducible use and imaging results,” said Alberto Spinazzi, MD, senior vice president, global medical and regulatory affairs, Bracco Group. “Our Varibar product line provides an unmet convenience for clinicians and removes the uncertainty that comes with measuring and mixing prior to testing patients. Varibar Pudding’s standard 40 per cent w/v ratio of barium sulfate concentration helps ensure uniform density, eliminating the potential for variability in results. This is our third FDA-approved barium-based contrast agent, which further serves as a testament to Bracco’s commitment to the diagnostic imaging community and the patients they serve.”
Varibar Pudding, formulated with a vanilla flavor for patient compliance, is one of the five viscosity ranges within the Varibar product family (Varibar Nectar (Target Viscosity 300 CPS) barium sulfate suspension (40% w/v, 30% w/w), Varibar thin honey (Target Viscosity 1500 CPS) barium sulfate suspension (40% w/v, 29% w/w), Varibar thin liquid barium sulfate suspension (40% w/v after reconstitution), VARIBAR® HONEY (Target Viscosity 3000 CPS) barium sulfate suspension (40% w/v, 29% w/w) and Varibar Pudding). Varibar Pudding is specifically formulated with the minimal coating properties necessary to clearly visualize the dynamic swallowing process. Each Varibar viscosity is formulated to provide pleasant, easily tolerated flavors, textures and consistencies, to help elicit a more natural swallowing action in patients who undergo x-ray MBS diagnostic studies to assess oropharyngeal function.