Barium Sulfate

Strategic decisions enable Bracco to serve better the needs of healthcare providers and patients with its enhanced pipeline offering MONROE TOWNSHIP, N.J., July 8, 2024 /PRNewswire/ -- Bracco Diagnostics Inc. (BDI), the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, is pleased to provide an update on its barium product portfolio as part of a comprehensive rationalization process. Bracco Diagnostics Inc. launched an initiative with its barium portfolio to invest in new and expanded product offerings driven by customer and patient demand. In addition, the company is pursuing FDA approval for its fourth product and expects to file for approval later this year. Upon anticipated approval, BDI will offer an enhanced line of FDA-approved barium products for abdominal imaging needs. "We remain committed to advancing the barium and oral imaging field," said Cosimo De Pinto, Senior Vice President of Sales and Marketing at BDI. "Our ongoing investment in new and expanded product offerings reflects our dedication to supporting healthcare providers in delivering exceptional patient care." At the same time, market changes and evolving procedural changes have led BDI to discontinue three of its non-FDA-approved barium products due to a significant decline in product usage. BDI does not anticipate discontinuing any additional barium products. "We understand the importance of providing high-quality diagnostic imaging solutions to our customers," continued Cosimo De Pinto. "Our rationalization process was essential to ensure that our resources are allocated effectively to meet the evolving needs of the medical community." As part of its commitment to innovation, BDI is excited to unveil its pipeline, providing a glimpse of its upcoming product launches over the next 24 months: Q3 2024: CitraClear™, a gutsy filling beverage, designed to enhance patient satisfaction during preparation for imaging procedures. Q4 2024: VARIBAR® (barium sulfate) "Mini" packaging, offering convenient and sustainable packaging options for healthcare facilities. 2025: Introduction of a new flavor in our CT barium line, further enhancing the patient experience during imaging examinations. BDI invites healthcare providers and industry partners to explore its barium pipeline and looks forward to continuing to collaborate in advancing diagnostic imaging technologies. INDICATIONS for VARIBAR® (barium sulfate) VARIBAR® THIN HONEY (barium sulfate) oral suspension, VARIBAR® NECTAR (barium sulfate) oral suspension, and VARIBAR® THIN LIQUID (barium sulfate) oral suspension are radiographic contrast agents 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 radiographic contrast agents 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 CONTRAINDICATIONS These products should not be used in patients with known or suspected perforation of the gastrointestinal (GI) tract; known obstruction of the GI tract; high risk of GI perforation such as those with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to the pelvis; high risk of aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation; known severe hypersensitivity to barium sulfate or any of the excipients of the product used. WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Barium sulfate preparations contain a number of excipients, including natural and artificial flavors, and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, and dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, food allergies, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction. Intra-abdominal Barium Leakage The use of VARIBAR PRODUCTS is contraindicated in patients at high risk of perforation of the GI tract. Administration of VARIBAR PRODUCTS may result in leakage of barium from the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation. Delayed Gastrointestinal Transit and Obstruction Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, constipation, pediatric patients with cystic fibrosis or Hirschsprung disease, and the elderly. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration after the barium sulfate procedure. When administering VARIBAR PUDDING, consider the administration of laxatives. Aspiration Pneumonitis The use of VARIBAR PRODUCTS is contraindicated in patients with trachea-esophageal fistula. Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. In patients at risk for aspiration, begin the procedure with a small ingested volume of VARIBAR PRODUCTS. Monitor the patient closely for aspiration, discontinue administration of VARIBAR PRODUCTS if aspiration is suspected, and monitor for development of aspiration pneumonitis. Systemic Embolization Barium sulfate products may occasionally intravasate into the venous drainage of the GI tract and enter the circulation as a "barium embolus" leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate. ADVERSE REACTIONS The most common adverse reactions are nausea, vomiting, diarrhea, and abdominal cramping. Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Please click here for full Prescribing Information for VARIBAR® THIN LIQUID (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® THIN HONEY (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® NECTAR (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® HONEY (barium sulfate) oral suspension. Please click here for full Prescribing Information for VARIBAR® PUDDING (barium sulfate) oral paste. 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. For additional information about Bracco's products, and for full prescribing information, please visit . About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom, and the United States. Bracco Group global revenues were 1.4 billion Euros in 2020. To learn more about Bracco Imaging, Bracco Diagnostics Inc. Media Relations (USA) Kimberly Gerweck Senior Manager, Marketing Communications [email protected] D: +1 609-524-2777 SOURCE Bracco Group

HSINCHU, March 18, 2024 /PRNewswire/ -- ICP DAS-BMP dazzled at the prestigious MD&M West Show, where its high-quality medical-grade thermoplastic polyurethane (TPU) garnered orders from top manufacturers in U.S. and Japan. Concurrently, part of the company's TPU products passed the ISO10993-6 test for local effects after 90-day implantation, positioning them as ideal materials for producing indwelling medical devices intended for use over 30 days. Continue Reading ICP DAS-BMP Secures Pivotal TPU Deals with Medical Materials Leaders in U.S. and Japan, Boosts Product Reliability ICP DAS-BMP Medical Grade TPU Biocompatibility and Other Testing ICP DAS-BMP, Asia's first medical-grade TPU supplier, produces three main series of products: Alithane™ (ALP series), Durathane™ (ALC series), and Arothane™ (ARP series). The company is set to launch a new Durathane™ (ARC series), known for its exceptional biostability. All the TPU series are available in different hardness levels, colors, and concentrations of radiopaque fillers (Tungsten/Barium Sulfate). These materials are widely utilized in manufacturing cardiovascular, urological, and gastrointestinal devices, as well as medical and electromedical consumables. ICP DAS-BMP's Arothane™ ARP-B20 (20% Barium Sulfate) and Durathane™ ALC-B40 (40% Barium Sulfate) passed the ISO10993-6 90-day implantation test. This qualifies them for long-term invasive or implantable medical applications such as peripherally inserted central catheters (PICC) and port-a-cath. The company plans to conduct long-term implantation tests for other specifications of TPU products based on customer demand, while advancing research and development to uphold TPU product quality. Medical-grade TPU differs from other plastics by emitting minimal VOCs during manufacturing and having low wastewater discharge, making it extremely environmentally friendly. It contains no plasticizers or heavy metals, ensuring excellent biocompatibility and blood compatibility, and enhancing ESG sustainability. ICP DAS-BMP aims to offer safer, stable, and eco-friendly medical-grade TPU, collaborating with global medical device manufacturers to create long-term benefits and value. Meet the company's experts at: CMEF (ICMD) 2024 (April 11-14) Booth Hall 8.1, M44, M46 NECC (Shanghai), China Medtec Japan 2024 (April 17-19) Booth 2022 Tokyo Big Sight East 2~3 Hall, Japan About ICP DAS-BMP ICP DAS-BMP, a Taiwan-based TPU manufacturer and supplier certified with ISO 13485, operates specialized laboratories dedicated to quality management. Drawing upon three decades of industrial automation expertise from its parent company ICP DAS, ICP DAS-BMP has implemented smart factory practices to enhance product quality and expedite delivery times. Additionally, the company provides responsive after-sales support and offers flexible solutions for small order quantities. For more information, please visit: For TPU products and inquiries, contact: [email protected] SOURCE ICP DAS Co., Ltd.