FDA approves Varibar Pudding from Bracco Diagnostics for MBS examinations

The FDA approved Varibar Pudding from Bracco Diagnostics for modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in patients six months and older.

Oropharyngeal impairment is caused by morbidity and disability that occurs from congenital abnormalities or neurologic causes for impaired swallowing. For patients to receive proper management and improve their outcomes, they will need accurate and reliable measures of oropharyngeal swallowing function. MBS studies using x-ray are the most effective way to examine the oral and pharyngeal phases of swallowing and to determine the extent of a 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, a senior vice president with Bracco Group, in a statement. "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 percent weight/volume 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."