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Octagos Health Secures Over $43 Million Investment to Advance AI-Driven Cardiac Device Monitoring

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HOUSTON, July 9, 2024 /PRNewswire/ — Octagos Health, an industry-leading provider of AI-driven cardiac device monitoring solutions, today announced a successful equity raise of over $43 million in investment capital. The Series B investment round was led by funds managed by Morgan Stanley Expansion Capital, with continued participation from Mucker Capital and other strategic investors. This funding will accelerate Octagos Health’s mission to use artificial intelligence to revolutionize cardiac care and provide comprehensive patient monitoring services. 

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Octagos Health provides an AI-driven platform that offers continuous monitoring and data analysis for patients with cardiac devices (pacemakers, defibrillators, ambulatory monitors, consumer wearables, and other modalities). Atlas AI, the company’s proprietary technology, ensures high accuracy and sensitivity in detecting clinically relevant events, automating physician workflows, and enabling healthcare providers to make informed decisions and improve patient outcomes. The platform’s comprehensive capabilities include seamless integration with electronic health records (EHR) and customizable reporting features, making it a preferred choice for cardiology practices. 

“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics.”

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“By combining AI, patient services, and bidirectional EHR integration, the Octagos Health platform enables cardiologists to efficiently monitor patients, improve patient care, and enhance clinic economics. The funding will help us accelerate our growth across the US and expand into other critical areas of cardiac care, including ambulatory monitors, consumer wearables, and sleep.  Our goal is to build a comprehensive AI-based clinical decision support engine for healthcare. We are thrilled to have Morgan Stanley Expansion Capital as our lead investor and the continued support of Mucker Capital. In a short period, we have grown from first servicing my cardiology clinic to becoming one of the largest cardiac remote monitoring companies that provides software and services,” said Dr. Shanti Bansal, cardiologist, CEO of Octagos Health and Houston Heart Rhythm. 
“This investment will enable us to accelerate enhancements to our platform, in addition to scaling our commercial team and operations. We are currently the only company that helps cardiology practices migrate their historical data from legacy software providers and fully integrates with any EHR system. We do this while enabling customized reporting supported by patient and practice decision-support analytics,” said Eric Olsen, COO of Octagos Health. “We are excited to partner with Octagos Health and support their vision of transforming cardiac care,” said Melissa Daniels, Managing Director of Morgan Stanley Expansion Capital. “Octagos Health has demonstrated exceptional growth and innovation in a critical area of healthcare. We believe their platform and vertically integrated software and services significantly improve patient care and streamline cardiac monitoring processes for healthcare providers.” “Octagos Health is poised for scale – industry leading gross margins, a very sticky product that doctors and clinical staff love, and a market ready for disruption with artificial intelligence. This is the new wave for diagnostic care,” said Will Hsu, Co-Founder and Partner at Mucker Capital. “This funding will help Octagos Health continue to add additional data sources from various diagnostic and consumer devices and further differentiate their offering.” About Octagos Health Octagos Health is a leading provider of cardiac monitoring solutions, dedicated to improving patient outcomes through advanced technology and comprehensive monitoring services. The company’s AI-driven platform offers continuous monitoring and data analysis for patients with implantable cardiac devices, enabling healthcare providers to make informed decisions and deliver timely care. Octagos Health’s solutions are designed to seamlessly integrate with electronic health records and provide customizable reporting features, making it an essential tool for modern healthcare institutions. For more information, please reach out to [email protected]. You can also follow us on LinkedIn. About Morgan Stanley Expansion Capital Morgan Stanley Expansion Capital is the growth-focused private investment platform within Morgan Stanley Investment Management. Morgan Stanley Expansion Capital targets growth equity and credit investments within technology, healthcare, consumer, and other high-growth sectors. For nearly four decades, Morgan Stanley Expansion Capital has successfully pursued growth investment opportunities and has completed investments in over 200 companies, leveraging the global brand and network of Morgan Stanley.About Mucker Capital Founded in Santa Monica, CA in 2011, Mucker Capital provides Pre-Seed, Seed, and Series A capital and support for startups in Southern California and in other, similarly underfunded ecosystems outside Silicon Valley.SOURCE Octagos Health, Inc.

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Centerline Biomedical joins ORSIF

Radiology by Comments are Disabled

Centerline Biomedical and ORSIF join together to raise awareness of health risks associated with fluoroscopic radiation and solutions available to medical professionals. 
CLEVELAND, July 9, 2024 /PRNewswire/ —  Centerline Biomedical, Inc. (“Centerline”), joins ORSIF, the organization for Occupational Radiation Safety in International Fluoroscopy, to raise awareness of technology options to improve safety in the work environment where fluoroscopic x-ray radiation is used in medical procedures. As a corporate partner, Centerline supports ORSIF (www.orsif.org) in a shared mission to champion innovation for safer healthcare. In addition, the developing platform aims to continue bringing together healthcare providers and their organizations, professional medical societies, and industry to provide education on radiation safety.
“We are proud to join ORSIF in its mission to create greater awareness in the medical community regarding the dangers of radiation exposure and to protect those who commit their lives to the wellness of others. To that end, IOPS® (Intra-Operative Positioning System) technology enables improved visualization with 3D navigation in endovascular procedures while minimizing the reliance on damaging radiation,” said Gulam Khan, CEO of Centerline Biomedical.  “Employees at Centerline are inspired every day to design the future of image guidance technology that enables faster, more precise transcatheter procedures while reducing the use of radiation.”  
Designed to mitigate radiation exposure during minimally invasive cardiovascular procedures, Centerline Biomedical IOPS (Intra-Operative Positioning System) is a novel technology gaining increased application in the US. IOPS includes software that creates 3D maps of vascular anatomy, enabling surgeons to visualize the arteries being treated. Using electromagnetic tracking, IOPS sensor-equipped guidewires and catheters can be guided in 3D as endovascular specialists navigate through these high-resolution intuitive visualizations during minimally invasive procedures. The images and tracking are displayed on an independent monitor, minimizing the reliance on damaging X-ray radiation typically used to produce live fluoroscopic images during interventions. 
About Centerline BiomedicalFounded in 2015, Centerline Biomedical is headquartered in Cleveland, Ohio. The company’s commercially available platform, IOPS®, Intra-Operative Positioning System, enables improved visualization and navigation in endovascular procedures. IOPS has 510(k) clearance from the US FDA for use in the descending aorta. The company continues investment in development to enhance the current technology platform and expand image guidance in transcatheter procedure applications.
Visit www.centerlinebiomedical.com for more information.
SOURCE Centerline Biomedical

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Neha Motwani Elected to Longeveron® Board of Directors

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MIAMI, July 09, 2024 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, including hypoplastic left heart syndrome (HLHS) and Alzheimer’s disease, today announced that Neha Motwani, a senior healthcare investment banker, has been elected to the Longeveron Board of Directors at the Company’s recent Annual Meeting of Stockholders. “I am delighted to welcome Neha, with her tremendous healthcare industry experience, to the Board of Directors,” said Joshua Hare, Co-founder, Chief Science Officer and Chairman of the Board at Longeveron. “Her extensive knowledge of biopharma company operations, financing and capital markets will bring significant value to Longeveron as we continue to advance Lomecel-B™, our proprietary, scalable, allogeneic cellular therapy. With five positive clinical trials across three indications, we believe Lomecel-B™ has the potential to be an important therapy for some of the most difficult diseases and conditions associated with aging.” Neha Motwani has over 25 years of healthcare investment banking experience, most recently serving as Managing Director, Healthcare Investment Banking at William Blair. She previously held investment banking roles of increasing responsibility with Truist Securities, Oppenheimer and Company, Stifel Financial and Cowen and Company, where, collectively, she completed transactions raising approximately $7.0 billion. Ms. Motwani earned her B.A. in political science from Columbia University. “I am delighted to join the Board of Directors of Longeveron at this exciting phase of the Company’s clinical development,” said Ms. Motwani. “I look forward to working with this talented team to continue their mission to advance their novel cellular therapy, Lomecel-B™ for the potential treatment of HLHS, a rare and devastating congenital heart condition, and diseases of the aging.” About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. The Lomecel-B™ HLHS program has received three distinct and important FDA designations: Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn, X, and Instagram. Investor Contact:Derek ColeInvestor Relations Advisory Solutionsderek.cole@iradvisory.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/00f0eb5c-76f5-49b1-9994-ee363513547b

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Pulnovo Medical Announces Joining PHA’s (Pulmonary Hypertension Association) Corporate Committee

Coronary/Structural Heart by Comments are Disabled

SHANGHAI, July 9, 2024 /PRNewswire/ — Pulnovo Medical, a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure, has recently announced its partnership with the Pulmonary Hypertension Association (PHA). This partnership not only underscores Pulnovo Medical’s growing global influence but also empowers PHA’s mission to extend and improve the lives of those affected by pulmonary hypertension (PH) worldwide.
Pulnovo Medical and the PHA are united by a collective vision to a future where pulmonary hypertension is better understood and more efficiently treated. Pulnovo Medical’s PADN technology, an innovative interventional therapy in the field of pulmonary hypertension, provides a new and beneficial solution for patients troubled by traditional drug treatments. Currently Pulnovo Medical is conducting global trials in US and Europe. This strategic partnership aims to combine Pulnovo Medical’s cutting-edge PADN therapies for Pulmonary Hypertension with PHA’s extensive network to enhance public awareness and improve the care of PH patients globally. As a member of PHA, Pulnovo Medical will actively participate in PHA’s educational programs, research projects and advocacy campaigns. Our collaboration will harness the urgency of our shared mission to make a lasting impact on pulmonary hypertension patients worldwide.
About PHA
The PHA was founded in 1991 in Florida and evolved into an international community of more than 16,000 people with PH, caregivers, family members and health care professionals. As one of the largest and oldest pulmonary hypertension association in the world, the PHA acts as a trusted liaison between the pulmonary hypertension community and industry and academic partners.
About PADN
Pulmonary Artery Denervation (PADN) is a percutaneous pulmonary artery intervention procedure that uses a PADN catheter to deliver radiofrequency energy to the sympathetic nerves in the outer membrane of the pulmonary artery, resulting in the disappearance of the myelin sheath of the nerves and the fusion of the axons, which inhibits sympathetic activity, increases cardiac output, reduces pulmonary artery pressure, inhibits the pathologic remodeling of the pulmonary arteries, improves the patient’s exercise endurance and cardiac function, and achieves long-term benefits from a single minimally invasive procedure.
About Pulnovo Medical
Pulnovo Medical Limited, is a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure, is committed to leveraging our deep expertise in the science of breakthrough technologies with the goal to market our innovative therapeutic solutions and benefit patients around the world.
For more information, please visit: www.pulnovomed.us

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Pulse Biosciences, Inc. Announces Receipt of FDA Breakthrough Device Designation for CellFX® nsPFA Cardiac Surgery System for the Treatment of Atrial Fibrillation

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MIAMI–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company” or “Pulse Biosciences”), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company’s Cardiac Surgery System for the ablation of cardiac tissue […]

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Reflow Medical Enrolls First Patients in Pilot Study of Coronary Sirolimus-Eluting Retrievable Scaffold System (Spur Elute)

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SAN CLEMENTE, Calif.–(BUSINESS WIRE)–Reflow Medical, Inc., a developer of innovative devices focused on cardiovascular disease, announces the first patient enrollments in “A pilot study of the Drug-Eluting Coronary Spur™ StEnt as a Primary trEatment for in-stent Restenosis (ISR) of the CORONARY arteries” (DEEPER CORONARY, NCT06117150). ISR is a common clinical problem that can generate significant […]

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Valcare Medical, Inc. Announces Formation of Scientific Advisory Board with Renowned Mitral Valve Experts

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TAMPA, Fla., July 2, 2024 /PRNewswire/ — Valcare Medical, Inc., a leading innovator in transcatheter-based mitral solutions, today announced the formation of a Scientific Advisory Board (SAB) comprised of distinguished experts. The SAB will provide expert insight and guidance while helping the Company further advance its research and development initiatives for the […]

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Vectorious Medical Technologies Reports Novel Findings From VECTOR HF Trials: Self-Management of Heart Failure Patients Using Left Atrial Pressure

Coronary/Structural Heart by Comments are Disabled

TEL AVIV, Israel, July 8, 2024 /PRNewswire/ — Vectorious Medical Technologies Ltd. announces the publication of a breakthrough pilot clinical study, which evaluated the V-LAP system and a novel therapeutic approach for heart failure, in the European Journal of Heart Failure.

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Vectorious: Self-Management of Heart Failure Patients Using Left Atrial Pressure via V-LAP to Prevent Disease Deterioration and Repeated Hospitalizations

Vectorious has developed a miniature digital pressure sensor (V-LAP) that measures left atrial pressure and is implanted in the heart’s interatrial septum using a minimally invasive catheterization procedure. The sensor transmits data that allows physician-directed, patient self-management of chronic heart failure, a prevalent and complex form of heart disease affecting approximately 1-2% of the population. Through a dedicated mobile application and based on daily data transmitted from the left atrium, patients self-adjust their diuretic dosage with the aim of preventing disease deterioration and repeated hospitalizations.

The study demonstrated for the first time that self-management of heart failure based on left atrial pressure (LAP) is both safe and feasible. At 12 months of follow-up, no complications or side effects related to the system were reported. Additionally, patient adherence to treatment was high, and significant improvements were observed in quality-of-life measures, coupled with a reduction in hospitalizations due to heart failure.
“This groundbreaking study marks a significant milestone in heart failure management by placing control directly in the hands of patients. This approach, akin to the empowerment seen in diabetes management, enables heart failure patients, under the guidance of their heart failure management team, to monitor and manage their condition safely with ease and confidence. By fostering greater patient autonomy, this innovative shift is set to dramatically enhance care quality and outcomes for this vulnerable population.” Said David Meerkin, MBBS, Interventional Cardiologist participating in the pilot VECTOR-HF study.To date, 55 V-LAP sensors have been successfully implanted in patients across Europe and Israel, accumulating over 40,000 days of LAP monitoring. This summer, implantations are planned to begin in leading heart centers in the United States, marking the next phase in the expansion of Vectorious’ clinical trials.”This study marks another significant step in realizing the transformative potential of patient self-management guided by left atrial pressure monitoring. By empowering patients with real-time hemodynamic data and decision-making tools, this innovative approach may not only enhance patient-centered outcomes but also shift the paradigm towards proactive and personalized heart failure care.” Said William T Abraham, Professor of Medicine from The Ohio State University Wexner Medical Center and one of the pioneers in implantable hemodynamic monitoring systems for heart failure patients.Eyal Orion, co-founder and CEO of Vectorious, added: “Publishing the research in a top-tier scientific journal is a historic milestone for the company, which has been developing not only one of the most complex medical systems but also a new therapeutic approach for over a decade. Transferring part of the responsibility to patients requires advanced, reliable, and accurate technology, and this is a challenge that requires perseverance and patience. We still have a way to go to fundamentally change the way the most common heart disease is understood and treated, but together with the amazing Vectorious team, physicians, and our partners, we are getting closer step by step.”About Vectorious Medical Technologies Ltd.Vectorious is a privately held company based in Tel Aviv, Israel, founded in 2011. The company’s V-LAP System enables heart failure patients to better control their disease by monitoring the heart’s Left Atrial Pressure (LAP) and detecting fluid accumulation in the earliest stages of the disease, prior to physiological symptoms. A mobile app further empowers patients to self-titrate medication in real-time based on data extracted from the heart. For more information, please visit the company website.Contact:Lili Arbely-ElbazVectorious Medical Technologies.+972-(0)525909192[email protected]Photo – https://mma.prnewswire.com/media/2455810/Vectorious_V_LAP.jpgSOURCE Vectorious Medical Technologies Ltd.

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Microbot Medical Enrolled the First Patient in its Pivotal Human Clinical Trial

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The first clinical case was performed at Brigham and Women’s Hospital The clinical trial is expected to support the future submission to the FDA for the commercialization of the LIBERTY® Endovascular Robotic Surgical System BRAINTREE, Mass., July 08, 2024 (GLOBE NEWSWIRE) — Microbot Medical Inc. (Nasdaq: MBOT) today announced the completion of the first procedure in a patient utilizing its LIBERTY® Endovascular Robotic Surgical System. The procedure took place at Brigham and Women’s Hospital (BWH), a leading academic medical center located in Boston, Massachusetts, as part of the Company’s pivotal human clinical trial. The clinical trial at BWH is led by Dr. Dmitry Rabkin, MD, PhD, Assistant Chief, Division of Angiography & Interventional Radiology, who also performed this first human case. The trial is part of the Investigational Device Exemption (“IDE”) for LIBERTY®, and the Company expects its results will support the future submission to the FDA and subsequent commercialization. “Enrolling the first patient in our pivotal human clinical trial is a significant milestone for the Company, and an important step on our journey to bring LIBERTY® to U.S. physicians,” commented Juan Diaz-Cartelle, MD, Chief Medical Officer of Microbot Medical. “We are very pleased with the rapid pace of site activation, and I’m looking forward to enrolling additional patients in the near future.” About Microbot Medical Microbot Medical Inc. (NASDAQ: MBOT) is a clinical- stage medical device company that specializes in transformational micro-robotic technologies, with the goals of improving clinical outcomes for patients and increasing accessibility through the natural and artificial lumens within the human body. The Investigational LIBERTY® Endovascular Robotic Surgical System aims to improve the way surgical robotics are being used in endovascular procedures today, by eliminating the need for large, cumbersome, and expensive capital equipment, while reducing radiation exposure and physician strain. The Company believes the LIBERTY® Endovascular Robotic Surgical System’s remote operation has the potential to be the first system to democratize endovascular interventional procedures. Further information about Microbot Medical is available at http://www.microbotmedical.com. Safe Harbor Statements to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Microbot Medical Inc. and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects” and “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, market conditions, risks inherent in the development and/or commercialization of the LIBERTY® Endovascular Robotic Surgical System, the outcome of its studies to evaluate the LIBERTY® Endovascular Robotic Surgical System, uncertainty in the results of pre-clinical and clinical trials or regulatory pathways and regulatory approvals, including whether the Company’s pivotal study in humans is successful, any failure or inability to recruit physicians and clinicians to serve as primary investigators to conduct regulatory studies which could adversely affect or delay such studies, disruptions resulting from new and ongoing hostilities between Israel and the Palestinians and other neighboring countries, any lingering uncertainty resulting from the COVID-19 pandemic, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional information on risks facing Microbot Medical can be found under the heading “Risk Factors” in Microbot Medical’s periodic reports filed with the Securities and Exchange Commission (SEC), which are available on the SEC’s web site at www.sec.gov. Microbot Medical disclaims any intent or obligation to update these forward-looking statements, except as required by law. Investor Contact: Michal Efraty IR@microbotmedical.com

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Bracco Diagnostics Inc. Announces Update on Product Portfolio

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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
CONTRAINDICATIONSThese 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 ReactionsBarium 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 www.fda.gov/medwatch 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 http://imaging.bracco.com/us-en. 
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 GerweckSenior Manager, Marketing Communications[email protected]D: +1 609-524-2777
SOURCE Bracco Group

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