Saturday, July 29, 2017
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved VARIBAR NECTAR (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders.
Trouble with swallowing is a frequent cause of morbidity and disability in all age groups, resulting from a wide spectrum of medical conditions, including patients with congenital abnormalities, infections, or connective tissue diseases, patients recovering from stroke, brain trauma, and/or coma, patients with masses of the tongue, pharynx, larynx, or retropharyngeal region, and follow-up of surgery and/or radiotherapy of brain or head and neck cancer. If not timely and properly detected and assessed, swallowing disorders may lead to dehydration, weight loss, aspiration pneumonia, airway obstruction, severely reduced quality of life, and even death.1
The MBS study, a radiological examination of the swallowing process, is key to determine the nature and extent of the swallowing disorder. The VARIBAR products are oral agents that provide adequate visibility of anatomical structures and the swallowing process during the MBS examination, and simulate different liquid and food consistencies to assess the type and severity of the swallowing disorder.
"Accurate and reliable measure of the swallowing process is key for proper patient management. The VARIBAR product line was developed in cooperation with speech language pathologists and radiologists to optimize the diagnostic performance and reliability of MBS studies," said Alberto Spinazzi, MD, Senior Vice President, Global Medical and Regulatory Affairs, Bracco Group. "This FDA approval provides physicians and patients with yet another FDA approved option within the VARIBAR product line, and reinforces our dedication to meet medical needs."
Spinazzi continued, "This FDA approval is a testament to the quality, safety and efficacy of this product family, which provides unmatched convenience with reproducible results."
Each VARIBAR product viscosity was formulated to provide pleasant, easily tolerated flavors, textures and consistencies, to help elicit a more natural swallowing action in patients who undergo an MBS study. The VARIBAR NECTAR product (Target Viscosity 300 CPS), formulated with an apple flavor for patient compliance, is one of the five viscosity ranges within the VARIBAR product line. The VARIBAR NECTAR product was developed specifically to provide the minimal coating properties necessary to clearly visualize the dynamic swallowing process.
VARIBAR products afford many benefits, including:
• Ensured consistency in barium density with 40% w/v across every formulation2-4
• Eliminating the need for additional food products and thickening agents2,5-7
• Clarifying viscosity terminology through scientific measurement versus subjective recipes2,3,5-8
• Avoiding undesirable coating inherent to traditional GI barium preparations4,9
• Supporting high-quality imaging4
• Enabling reproducible results2-10
The remaining four VARIBAR products include VARIBAR® PUDDING (barium sulfate) oral paste, VARIBAR® THIN HONEY BARIUM SULFATE SUSPENSION (40% w/v, 29% w/w) (Target Viscosity 1500 CPS), VARIBAR® THIN LIQUID BARIUM SULFATE SUSPENSION (40% w/v after reconstitution) (Target Viscosity 4 CPS)* and VARIBAR® HONEY BARIUM SULFATE SUSPENSION (40% w/v, 29% w/w) (Target Viscosity 3000 CPS).
