Heart Septal Defects, Atrial

THURSDAY, Jan. 25, 2024 -- The risk for congenital malformations is lower in association with buprenorphine versus methadone for opioid use disorder in pregnancy, according to a study published online Jan. 22 in JAMA Internal Medicine . Elizabeth A. Suarez, Ph.D., M.P.H., from Brigham and Women's Hospital and Harvard Medical School in Boston, and colleagues compared the risk for congenital malformations following in utero exposure to buprenorphine versus methadone in a population-based cohort study using data from publicly insured Medicaid beneficiaries from 2000 to 2018. Data were included for 13,360 pregnancies with enrollment from 90 days prior to pregnancy start through one month after delivery ; first-trimester buprenorphine or methadone use was linked to infant outcomes. Overall, 9,514 pregnancies with first-trimester buprenorphine exposure and 3,846 with methadone exposure were included in the cohort. The researchers found that the risk for malformations was 50.9 and 60.6 per 1,000 pregnancies for buprenorphine and methadone, respectively. After confounding adjustment, buprenorphine was associated with a lower risk for malformations compared with methadone (risk ratio [RR], 0.82). For buprenorphine, risk was lower for cardiac malformations (RR, 0.63), including ventricular septal defect and secundum atrial septal defect/non-prematurity-related patent foramen ovale (RRs, 0.62 and 0.54, respectively), oral clefts (RR, 0.65), and clubfoot (RR, 0.55). Given low event counts, results for neural tube defects were uncertain. "The small increase observed in the risk of malformations with methadone use compared with buprenorphine likely does not exclude methadone as the best treatment choice for some pregnant individuals, particularly those on stable treatment prior to pregnancy or patients who do not respond well to buprenorphine," the authors write. Several authors disclosed ties to industry. Abstract/Full Text (subscription or payment may be required) Editorial (subscription or payment may be required) Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions. Posted January 2024 More news resources FDA Medwatch Drug Alerts Daily MedNews News for Health Professionals New Drug Approvals New Drug Applications Drug Shortages Clinical Trial Results Generic Drug Approvals Subscribe to our newsletter Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

JUPITER, Fla.--( BUSINESS WIRE )--Cognigenics, Inc., is pioneering next-generation therapeutic approaches to treating mental health, neuropsychiatric and neurodegenerative disorders. Our proprietary platform technology employs genetic neuroengineering to accurately and noninvasively target well established neural networks in the brain associated with conditions such as anxiety, cognitive decline and memory. The company announced today its participation in the upcoming Biotech Showcase™ 2024. This prestigious event is set to take place alongside the globally recognized J.P. Morgan Annual Healthcare Conference in San Francisco. Dr. Tracy Brandmeyer, Chief Technology Officer, will be presenting at the event, providing an update on the company's latest research and development initiatives, including an update on the Company’s lead product candidate, COGN-201, which is entering IND-enabling studies, targeting a range of indications associated with anxiety and cognitive decline. The company is also available for one-on-one meetings. PRESENTATION DETAILS Where: Hilton San Francisco Union Square Date: Wednesday, January 10, 2024 Time: 11:00 am Room: Yosemite - C ABOUT COGN-201 COGN-201 is a novel, RNA-based, intranasally delivered neuromodulating therapeutic agent, designed to address a range of mental health and neuropsychiatric indications. In preclinical in vivo studies, COGN-201 has shown promising activity, suggesting potential benefits for individuals experiencing anxiety associated with mild cognitive impairment (MCI). Its unique mechanism targets neural pathways to support brain health. ABOUT COGNIGENICS Cognigenics is pioneering the frontier of RNA-based therapeutics for mental health, neuropsychiatric and neurodegenerative disorders. Our proprietary platform employs genetic neuroengineering methods to accurately and noninvasively target the neural networks associated with conditions such as anxiety, depression, cognitive decline and memory. Utilizing RNA-based delivery methods, our platform technology mitigates the harmful consequences of chronic stress and disorders arising from chronic neural dysregulation, including (but not limited to) Anxiety Spectrum Disorders (ASD), Mild Cognitive Impairment (MCI), and Alzheimer’s Disease (AD). Using cutting-edge gene editing technology, our therapies are designed to address specific pathophysiological aspects of mental health, neuropsychiatric and neurodegenerative disorders. Our preclinical studies suggest that our interventions may have the potential to yield high efficacy rates in symptom management with a favorable safety profile, significantly reducing the burden of these conditions.

SCHAFFHAUSEN, CH / ACCESSWIRE / January 8, 2024 / Occlutech Holding AG Occlutech ASD Occluder delivers positive procedural outcomes with strong efficacy and a low rate of complications[i] Occlutech®, a world leading specialist provider of minimally invasive structural heart implants, today announced that the United States Food and Drug Administration (FDA) has approved the Occlutech® ASD Occluder and Occlutech® Pistol Pusher for the treatment of Atrial Septal Defects (ASD). With this approval, Occlutech will immediately begin commercialization in an exclusive partnership with distributor B. Braun Interventional Systems Inc. (B. Braun Interventional Systems). ASDs are one of the most common congenital heart defects (CHD) seen in pediatric cardiology[ii]. An ASD is a hole in the septum, or wall, between the two upper chambers of the heart (atria)[iii]. This opening causes abnormal blood flow between the atria and may result in too much blood flow to the lungs. If left untreated, an ASD can lead to fatigue, shortness of breath, pulmonary hypertension, heart failure, arrhythmia and/or an enlarged heart. Sabine Bois, Occlutech CEO commented, "Today marks a momentous occasion for Occlutech and a significant leap forward in our commitment to advancing healthcare around the globe. I am thrilled the FDA has granted approval for the Occlutech ASD Occluder and Occlutech Pistol Pusher. Our mission has always been to improve the quality of life for patients; indeed, we have sold over 90,000 of our ASD devices outside of the U.S. Now, with the FDA's approval, we are poised to leverage our experience in the largest congenital and structural heart disease market in the world, with ASD closure representing a $40 million market in the US with solid growth predicted. Bois continued, "We extend our deepest gratitude to the patients, partners and all stakeholders who have been instrumental in this journey." An ASD can be closed by a minimally invasive procedure. A catheter is inserted via a blood vessel in the groin and guided to the heart. The Occlutech ASD Occluder is a self-expanding Nitinol double disc occlusion device comprised of two umbrella-shaped flexible discs with a ‘waist' in the middle that connects the two discs. Designed to be a lifelong solution, the discs attach to both sides of the atrial septum, bridging the defect and closing the hole. Prof. Ziyad M. Hijazi, Chairman, Department of Cardiovascular Diseases and Professor of Pediatrics & Medicine, Sidra Medicine and Weill Cornell Medicine- Doha commented, " This landmark approval is a huge milestone. The Occlutech ASD Occluder has demonstrated excellent procedural outcomes and a low complication rate, per rigorous scientific study and clinical trials of >5000 studied patients in retrospective, prospective and randomized clinical trials as well as comparative meta-analysis. Therefore, to have the device available to our patients in the U.S. will only serve to help thousands more people in need." In an agreement signed May 2022, B. Braun Interventional Systems will immediately initiate the U.S. commercialization activities for the Occlutech ASD Occluder with the support of the global Occlutech team. Through the collaboration, Occlutech positions itself for success in the strategically important U.S. market, which is characterized as a premier and commercially attractive healthcare system, while B. Braun Interventional Systems increases its portfolio's relevancy around its strong congenital and structural heart focus. "We are honored to bring the trusted Occlutech ASD Occluder, with its strong body of clinical evidence into our portfolio of devices developed to treat congenital heart defects,[i,iv] " said Dave Mittl, VP Sales and Marketing, B. Braun Interventional Systems. " Our legacy at B. Braun Interventional Systems has been to deliver solutions to interventionalists treating these often-overlooked patients. This portfolio addition builds on that commitment, " Mittl concluded. - Ends - About Occlutech Occlutech is a leading specialist provider of minimally invasive structural heart devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a leading global specialist in cardiac devices, addressing congenital heart defects, stroke prevention and heart failure. Since 2003, the company has developed, manufactured, and commercialized occluders and interatrial shunt products. Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with over 177,000 products sold. The company markets and sells its products in approximately 85 countries. The company has around 350 employees and is a public limited liability company registered in Switzerland. For more information, connect with Occlutech on LinkedIn . For U.S. important safety information on the Occlutech ASD Occluder, visit: About B. Braun Interventional Systems Inc. B. Braun Interventional Systems offers interventional solutions designed with the patient in mind. Many of the products offered have been developed in response to the needs of physicians, technicians, and nurses. The company is committed to delivering safety, precision, and convenience to interventional procedures. B. Braun Interventional Systems Inc. is part of the B. Braun Group of Companies in the U.S., which is headquartered in Bethlehem, PA., and includes B. Braun Medical Inc., Aesculap® and CAPS®. Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Interventional Systems Inc., visit and connect with B. Braun Interventional Systems on LinkedIn. For more information contact: Rebecca Fancini Occlutech Public Relations +44 (0) 7594 649094 rebecca.fancini@occlutech.com Judy Marushak Director, Marketing Communications B. Braun Medical Inc. 610-217-4964 judy.marushak@bbraunusa.com References: [i]Kenny, D. et al. A randomized, controlled, multi-center trial of the efficacy and safety of the Occlutech Figulla Flex-II Occluder compared to the Amplatzer Septal Occluder for transcatheter closure of secundum atrial septal defects. Catheterization and Cardiovascular Interventions 93, (2018). [ii] Moake, L., & Ramaciotti, C., Atrial Septal Defect Treatment Options (2005). AACN Clinical Issues, 16(2), 252-266. [iii] Kuijpers et al., Secundum atrial septal defect in adults: a practical review and recent developments, Neth Heart J. 2015 Apr; 23(4): 205-211 [iv] Haas N et al. Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series Catheter Cardiovasc Interv. 2016. DOI: 10.1002/ccd Attachments Occlutech® Announces FDA Approval of its Occlutech® ASD Occluder and Occlutech® Pistol Pusher, a Minimally Invasive Cardiac Device and Delivery System to Treat Atrial Septal Defects SOURCE: Occlutech Holding AG View the original press release on accesswire.com