MONROE TOWNSHIP, N.J., June 19, 2019 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, acknowledges Speech Language Pathologists (SLPs) for their important role in the diagnosis, treatment and management of patients with dysphagia during June, which is designated Dysphagia Awareness Month by the National Foundation of Swallowing Disorders.
Dysphagia or difficulty in swallowing affects approximately one in 25 people according to the American Speech-Language-Hearing Association (ASHA), and it is more common among older individuals.1 Its prevalence is expected to increase as the U.S. population continues to age. 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.1
The most common complications are aspiration pneumonia, malnutrition and dehydration.2 Aspiration pneumonia is a subset of pneumonia caused by inhalation of oropharyngeal secretions, liquid and/or food colonized by pathogenic bacteria. It requires hospitalization and is associated with 10% in-hospital mortality and high hospitalization cost, estimated at approx. $30,000 per case.3
SLPs are healthcare professionals who specialize in, and play a critical role in, the diagnosis and management of patients with dysphagia, and other conditions that affect swallowing and speech. A modified barium swallow study (MBS) is an important diagnostic imaging tool to detect and assess the severity of swallowing disorders.
During this imaging study, a patient swallows preparations of different thicknesses containing barium sulfate, while the Radiologist takes fluoroscopic x-ray images. The study's results enable the clinical team to optimize patient management and prevention of complications.
"In cooperation with leaders of the SLP profession, Bracco developed VARIBAR® products, a line of ready-to-use* imaging agents for MBS exams with a fixed concentration of barium sulfate and standardized and premeasured viscosities, to guarantee reproducibility and accurate comparisons between initial and follow-up studies," said Alberto Spinazzi, MD, Senior Vice President, Chief Medical and Regulatory Officer, Bracco Group. "The VARIBAR imaging agents are the only barium products approved by the U.S. Food and Drug Administration for use in MBS studies." Spinazzi continued, "Patients are at the core of what we do at Bracco, and we are proud that we offer products that play a vital role in the management of patients who suffer from dysphagia."
*VARIBAR THIN LIQUID (barium sulfate) oral suspension requires reconstitution prior to use
Please see Important Safety Information below.
Indications and Usage:
VARIBAR® THIN HONEY (barium sulfate) oral suspension, VARIBAR® NECTAR (barium sulfate) oral suspension, and VARIBAR® THIN LIQUID (barium sulfate) for oral suspension, are indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR® HONEY (barium sulfate) oral suspension and VARIBAR® PUDDING (barium sulfate) oral paste are indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.
IMPORTANT SAFETY INFORMATION:
For Oral Administration. This product should not be used in patients with known or suspected perforation of the GI tract, known obstruction of the GI tract, high risk of aspiration, or hypersensitivity to barium sulfate products. Rarely, severe allergic reactions of anaphylactoid nature have been reported following administration of barium sulfate contrast agents. Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration.
Please consult full Prescribing Information for the VARIBAR family of products at https://imaging.bracco.com/us-en/products/fluoroscopy/varibar
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm or call 1-800-FDA-1088.
VARIBAR is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 08831.
VARIBAR is a registered trademark of E-Z-EM, Inc.
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world's leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.
Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.
The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.
Operational investments have been made in order to achieve top quality, compliant and sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.
Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and the USA.
To learn more about Bracco Imaging, visit www.braccoimaging.com.
Bracco Diagnostics Inc.
- Bhattacharyya N. The prevalence of dysphagia among adults in the United States. Otolaryngology–Head and Neck Surgery 2014; 151: 765–769
- Schindler A, Ginocchio D, Ruoppolo G. What we don't know about dysphagia complications? Rev Laryngol Otol Rhinol (Bord) 2008;129:75-88
- Wu C-P, Chen Y-W, Wang M-J, and Pinelis E. National Trends in Admission for Aspirational Pneumonia in the United States, 2002-2012; AnnalsATS 2017, 14: 874-879
SOURCE Bracco Diagnostics Inc.