Foramen Ovale, Patent

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.

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

Amsterdam-based Philips presented its findings at ACC.23/WCC in New Orleans. Results included trends with intravascular imaging, early cardiac implant removal and intracardiac echocardiography catheters. “To make a real difference to patients, it is vitally important that medical innovations are validated in real-life clinical practice so that clinician decision-making and guideline setting are firmly evidence-based. At Philips, we are deeply committed to making sure this is the case,” said Dr. Atul Gupta, CMO for image-guided therapy at Philips. “The positive clinical study results announced today are further evidence of how we are continuously working with our clinical partners to co-create new innovations and demonstrate how they improve outcomes for patients.” Philips evaluates intravascular imaging during percutaneous coronary intervention Dr. Reza Fazel, an interventional cardiologist at Beth Israel Deaconess Medical Center in Boston, presented initial results from real-world Medicare data. The data analyzed more than 1 million patients to evaluate trends with intravascular imaging (IVI) during PCI procedures. Dr. Eric Secemsky, director of vascular intervention at BIDMC, led the study. Data evaluated more than 1 million patients undergoing PCI procedures between Jan. 1, 2013, and Dec. 31, 2019. Preliminary results revealed that IVI use as an adjunct to angiography rose by 62% during the period. Researchers associated this rise with superior patient outcomes. Philips’ IVI offering includes intravascular ultrasound catheters, co-registration and automated measurement tools. These can accompany the Philips Azurion image-guided therapy system. Removal of infected cardiac implantable electronic devices (CIEDs) Dr. Sean Pokorny presented results quantifying reduced hospital costs related to the early removal of CIEDs. Pokorney serves as assistant professor of medicine and a member of the Duke Clinical Research Institute at Duke University School of Medicine. Pokorney and his team at Duke analyzed the records of more than 1 million CIED implant patients in the “U.S. 100% Medicare fee-for-service” population. The analysis covered the period between Jan. 1, 2006, to Dec. 31, 2019. Of the 9,867 patients diagnosed with a CIED infection 12 months or more after implantation, only 13.3% underwent extraction within six days. Only 5.2% underwent extraction between seven and 30 days, according to Philips. “This data highlights a major gap in care among our CIED infection patients, which results in higher mortality, more health care utilization, and higher cost of care. Quality improvement interventions with focused systems of care are needed to optimize patient outcomes,” said Pokorney. Complete device extraction within six days of infection diagnosis was associated with lower (21%) all-cause hospitalization in follow-up. It also led to 42% lower healthcare expenditure compared those without device extractions. Timely extraction led to lower hospitalization rates, too, Philips said. “CIED infection is a healthcare crisis, and EMR (electronic medical records) are essential in identifying patients and minimizing time to extraction,” said Dr. John Andriulli. “It must be ubiquitously shared between hospital systems to improve length of stay and more importantly to impact the potential reduction in mortality. This is especially true for outside hospital transfers. This is when the EMR becomes even more important.” Philips reports on 3D intracardiac echocardiography Dr. Mohamed Alkhouli, professor of medicine at Mayo Clinic School of Medicine, presented real-world safety and performance results. This study evaluated the Philips VeriSight Pro 3D ICE intracardiac echocardiography catheter in image-guided, minimally invasive cardiac procedures. The prospective, non-randomized, multi-center, observational study evaluated 155 patients. These patients underwent evaluation for a range of percutaneous cardiac intervention procedures. Philips said it included left atrial appendage occlusion (LAAO), cardiac ablation, heart valve replacement, and patent foramen ovale (PFO). It also featured atrial septal defect (ASD — “hole in the heart” — repair procedures. Philips designed its ICE catheter with a tip-mounted ultrasound transducer. The surgeon can route the catheter to the heart via the blood vessels and a small incision in the skin. Philips said ICE represents a more comfortable option than a transesophageal echocardiogram (TEE). It also requires less sedation or anesthesia. The study evaluated patients until discharge or 48 hours after their procedure. It demonstrated safety with no reported periprocedural device-related adverse events. VeriSight Pro 3D ICE demonstrated acceptable or better image quality compared to TEE or competitive ICE technology in more than 95% of procedures. Philips said it also proved an acceptable or better surrogate to TEE 89.7% of the time.