Bracco Diagnostics Receives FDA Approval for VARIBAR® THIN LIQUID

Bracco Diagnostics announced FDA approval for VARIBAR® THIN LIQUID (barium sulfate) for oral suspension which is indicated for modified barium swallow (MBS) studies used to detect and assess the type and severity of swallowing disorders also known as dysphagia.

In the U.S., approximately 13 million (1 in 25) Americans suffer from dysphagia. Dysphagia varies in severity and can be caused by a number of conditions and diseases, such as stroke, traumatic brain injury, dementia, Parkinson's disease, multiple sclerosis, and treatment of head and neck cancer or trauma. The most common complications are aspiration pneumonia, malnutrition and dehydration. Aspiration pneumonia is a subset of pneumonia caused by inhalation of substances such as liquid and/or food into the lungs when the swallowing mechanism does not function properly. It requires hospitalization and is associated with 10% in-hospital mortality and high hospitalization cost, estimated at approx. $30,000 per case.

An MBS study is performed by a team comprised of a speech language pathologist (SLP) and a radiologist to identify issues with a patient's swallowing mechanism. During an MBS, the patient swallows products with different thicknesses containing a barium x-ray contrast agent, while the Radiologist takes fluoroscopic x-ray images.

"The FDA approval of VARIBAR® THIN LIQUID (barium sulfate) for oral suspension represents an important event for patients who suffer from dysphagia and require a modified barium swallow study to determine their best management," said Alberto Spinazzi, MD, Senior Vice President, Chief Medical and Regulatory Officer, Bracco Group. "FDA has now granted approval to the entire line of the VARIBAR imaging agents. This means that all VARIBAR products meet the safety, efficacy and quality standards of the FDA. We are proud of the fact that VARIBAR products are the only imaging agents approved for use in MBS studies. This line of ready-to-use imaging agents has a fixed concentration of barium sulfate and standardized and premeasured viscosities, to guarantee reproducibility and accurate comparisons between initial and follow-up studies."

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