Latest news with #ischemic
Medscape
16-07-2025
- Health
- Medscape
Does Romosozumab Deserve Its Black Box Warning?
Osteoporosis drug romosozumab showed no increased risk for the development of cardiovascular (CV) events compared with anabolic osteoporosis drugs, contrary to its black box warning, new research found. 'These findings suggest there is no heightened risk for major adverse cardiovascular events in patients with osteoporosis treated with romosozumab compared to the anabolic agents teriparatide or abaloparatide,' the authors reported at ENDO 2025: The Endocrine Society Annual Meeting. 'Further observational data is required to concur with such findings, which may lead to a discontinuation of the black box warning,' they said. Romosozumab, a monoclonal antibody targeting sclerostin, has a unique dual action of anabolic properties (increasing bone formation while reducing resorption and improving bone mineral density while reducing vertebral fracture risk). The drug is injected monthly for 12 months, after which time its anabolic effects decline and patients must transition to other antiresorptive therapies, such as bisphosphonates or denosumab, to maintain gains in bone density. Although the FDA approved romosozumab for osteoporosis management, it has given a black box warning after clinical trials (including the ARCH study) comparing romosozumab with alendronate suggested an increased risk for serious CV events, including myocardial infarction, stroke, and CV death. The drug is therefore contraindicated in patients with hypocalcemia and those who have had a myocardial infarction or stroke within the previous year. However, data on those risks has been highly inconsistent, first author Maxim John Levy Barnett, MD, of Jefferson-Einstein Hospital, Philadelphia, told Medscape Medical News . 'Most previous studies on this issue show a nonsignificant trend toward a higher risk but do not reach statistical significance,' he said. Even the ARCH trial 'showed a trend of higher incidence of adverse outcomes, but it was not statistically significant,' he noted. New Findings To further investigate the risks, Barnett and colleagues evaluated data on patients with osteoporosis in the TriNetX database, including 14,760 patients treated with romosozumab and 45,302 treated with either teriparatide or abaloparatide anabolic agents. For the propensity score analysis, patients in the two groups were matched for age, sex, race, glycated hemoglobin, hypertension, chronic kidney disease, ischemic heart disease, cerebrovascular disease, diabetes, and other factors. After matching, the romosozumab group had 14,288 patients compared with 14,362 in the anabolic agent group. Patients had a mean age at baseline of 70.5 years, 94% were women — as the drug is approved in the US for women only — and 71% were White. With a mean follow-up of 5 years (including the 1-year treatment with romosozumab), there was a nonsignificant trend toward a reduced risk for CV incidents among those treated with romosozumab (relative risk [RR], 0.601; P = .0692). The romosozumab group also had significantly lower ischemic heart disease rates than the anabolic agent group (RR, 0.848; P = .0017). In addition, those receiving romosozumab had a lower risk of acute myocardial infarction (RR, 0.654; P < .0001). Likewise, acute heart failure, either systolic or diastolic, was also significantly lower in the romosozumab group (RR, 0.664; P = .0029). 'After propensity-score matching, there was still a significant reduction [with romosozumab], which was a surprise,' Barnett said. 'Three out of the 4 outcomes actually showed a significant decrease in risk with romosozumab.' 'To the best of my knowledge, similar trends have not been noted in other studies,' he said, adding that there have been no significant changes to romosozumab's treatment regimen or other factors that might explain differences in risk since the issuance of the black box warning. 'It is important to note that this was not the primary objective of the noninferiority study, and it was not powered for this endpoint,' Barnett said. The findings nevertheless add to evidence from others showing results that call into question the concerns behind the black box warning. 'There is no substantial evidence for cardiovascular risk and this medication; nonetheless, the black box warning is present,' Barnett said. Commenting on the study, Tiffany Kim, MD, of the University of California, San Francisco, who co-moderated the session, agreed that 'these are definitely interesting findings that add to growing data that romosozumab may not be associated with increased cardiovascular risk.' She noted that, as intended, 'any black box warning has a big effect on how clinicians consider and talk to a patient about the risks of a medication.' 'From a medico-legal perspective, I always inform my patient so they aren't surprised if they read this later, and so that I can document that they accept the benefits outweigh the risk for their individual situation.' 'This study adds to the reassuring literature that romosozumab may not be associated with increased risk of cardiovascular disease,' Kim said. 'In my clinical practice, I only consider anabolic therapy for my patients with severe osteoporosis at high fracture risk who really need treatment, so having more data about the CV risk helps with my clinical decision-making and with discussions with my patients about the risks and benefits of this drug.' In terms of caveats, Kim noted that 'the study did a good job of matching for medical comorbidities, but there may be other factors that cause a clinician to prescribe the drugs that are associated with cardiovascular disease.' 'This study is a helpful addition to the literature, but it's hard to be definitive in an observational study,' she added.
Business Wire
18-06-2025
- Business
- Business Wire
ANACONDA Biomed Receives CE Mark for Its ANA5 Funnel Catheter to Treat Ischemic Stroke
BARCELONA, Spain--(BUSINESS WIRE)--ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark certification for its ANA5 Funnel Catheter. The CE marking confirms that the ANA5 device complies with the European Union's health, safety, and environmental protection standards, enabling its eventual commercial viability across the EU. The CE Mark approval is supported by a comprehensive body of evidence, including preclinical bench and animal studies, and clinical data from the recently published ANAIS study demonstrating high reperfusion and first-pass success rates. Share The ANA5 Funnel Catheter is engineered to optimize mechanical thrombectomy by maximizing clot capture with its vessel-matching diameter funnel. Simultaneously, it enables antegrade flow arrest and offers the potential for flow reversal, enhancing aspiration-assisted clot retrieval. The ANA5 promotes improved clot capture and removal through its unique proprietary geometry. The CE Mark approval is supported by a comprehensive body of evidence, including preclinical bench and animal studies, and clinical data from the recently published ANAIS study demonstrating high reperfusion and first-pass success rates. Further clinical validation is ongoing in the ATHENA trial, a prospective, multicenter randomized study systematically evaluating the impact of proximal flow arrest on reperfusion effectiveness, to support future regulatory submissions and commercialization efforts in the United States. " Receiving CE Mark approval is a pivotal achievement for ANACONDA Biomed that advances our mission to innovate in the interventional management of acute ischemic stroke," said Trent Reutiman, chief executive officer. " This milestone reflects the strength of our science and the dedication of our team. We now have the capability of making ANA5 available to clinicians across Europe, bringing this innovative technology to broader stroke application." Dr. Marc Ribo, the co-founder of Anaconda Biomed, added, " Receiving CE Mark approval for ANA5 is deeply meaningful, as it represents the culmination of years of research, iteration, and belief in an idea that began at the bench. This is more than a regulatory milestone; it's the moment where innovation becomes impact. We're now gearing up to capture real-world data by collecting more invaluable insight into how ANA5 performs across diverse stroke centers and clinical realities." About ANA Funnel Catheter ANA5 Advanced Neurovascular Access™ (ANA Funnel Catheter) is designed as an expandable and collapsable funnel catheter for interventional neurovascular procedures, requiring the retrieval of clot, and benefiting from limiting flow and/or flow reversal towards that goal. The device consists of a radiopaque nitinol braid funnel, covered with a polymeric coating enabling local flow arrest. The catheter is currently an investigational device and is not available for sale in the United States. About Anaconda Biomed Anaconda Biomed is an innovative medical technology company dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. At the heart of its product portfolio is the ANA Funnel Catheter. Anaconda Biomed has received funding from prominent life science investment firms, including Ysios Capital, Omega Funds, Innogest, Asabys Partners, Banco Sabadell, and private investors. Additionally, through public grants, the company has received significant public support from ENISA, CDTI (Innvierte and NEOTEC), the Ministry of Science & Innovation (Emplea and Retos), EIB, and EIT Health. For more information, please visit and follow the company on LinkedIn.
Yahoo
18-06-2025
- Business
- Yahoo
ANACONDA Biomed Receives CE Mark for Its ANA5 Funnel Catheter to Treat Ischemic Stroke
Clinical Evidence Shows High Reperfusion and First Pass Success Rates with the Device BARCELONA, Spain, June 18, 2025--(BUSINESS WIRE)--ANACONDA Biomed, a medical technology company developing next-generation thrombectomy systems for the treatment of ischemic stroke, has announced that it has received CE Mark certification for its ANA5 Funnel Catheter. The CE marking confirms that the ANA5 device complies with the European Union's health, safety, and environmental protection standards, enabling its eventual commercial viability across the EU. The ANA5 Funnel Catheter is engineered to optimize mechanical thrombectomy by maximizing clot capture with its vessel-matching diameter funnel. Simultaneously, it enables antegrade flow arrest and offers the potential for flow reversal, enhancing aspiration-assisted clot retrieval. The ANA5 promotes improved clot capture and removal through its unique proprietary geometry. The CE Mark approval is supported by a comprehensive body of evidence, including preclinical bench and animal studies, and clinical data from the recently published ANAIS study demonstrating high reperfusion and first-pass success rates. Further clinical validation is ongoing in the ATHENA trial, a prospective, multicenter randomized study systematically evaluating the impact of proximal flow arrest on reperfusion effectiveness, to support future regulatory submissions and commercialization efforts in the United States. "Receiving CE Mark approval is a pivotal achievement for ANACONDA Biomed that advances our mission to innovate in the interventional management of acute ischemic stroke," said Trent Reutiman, chief executive officer. "This milestone reflects the strength of our science and the dedication of our team. We now have the capability of making ANA5 available to clinicians across Europe, bringing this innovative technology to broader stroke application." Dr. Marc Ribo, the co-founder of Anaconda Biomed, added, "Receiving CE Mark approval for ANA5 is deeply meaningful, as it represents the culmination of years of research, iteration, and belief in an idea that began at the bench. This is more than a regulatory milestone; it's the moment where innovation becomes impact. We're now gearing up to capture real-world data by collecting more invaluable insight into how ANA5 performs across diverse stroke centers and clinical realities." About ANA Funnel Catheter ANA5 Advanced Neurovascular Access™ (ANA Funnel Catheter) is designed as an expandable and collapsable funnel catheter for interventional neurovascular procedures, requiring the retrieval of clot, and benefiting from limiting flow and/or flow reversal towards that goal. The device consists of a radiopaque nitinol braid funnel, covered with a polymeric coating enabling local flow arrest. The catheter is currently an investigational device and is not available for sale in the United States. About Anaconda Biomed Anaconda Biomed is an innovative medical technology company dedicated to developing next-generation thrombectomy systems for the treatment of ischemic stroke. At the heart of its product portfolio is the ANA Funnel Catheter. Anaconda Biomed has received funding from prominent life science investment firms, including Ysios Capital, Omega Funds, Innogest, Asabys Partners, Banco Sabadell, and private investors. Additionally, through public grants, the company has received significant public support from ENISA, CDTI (Innvierte and NEOTEC), the Ministry of Science & Innovation (Emplea and Retos), EIB, and EIT Health. For more information, please visit and follow the company on LinkedIn. View source version on Contacts MEDIA CONTACT: Joe DuraesPazanga Health Communications jduraes@ 917-687-6419 Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
06-06-2025
- Health
- Yahoo
Novo Nordisk's Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say
The European Medicines Agency's (EMA) safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause vision loss. Novo Nordisk A/S's (NYSE:NVO) semaglutide, a GLP-1 receptor agonist, is the active substance in certain medicines used for diabetes and obesity (Ozempic, Rybelsus, and Wegovy). After reviewing all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials, post-marketing surveillance and the medical literature, the committee on Friday concluded that NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide).Results from several large epidemiological studies suggest that exposure to semaglutide in adults with type 2 diabetes is associated with an approximately two-fold increase in the risk of developing NAION compared with people not taking the medicine. This corresponds to approximately one additional case of NAION per 10,000 person-years of treatment; one person-year corresponds to one person taking semaglutide for one year. Data from clinical trials also point to a slightly higher risk of developing the condition in people taking semaglutide compared with people taking a placebo (a dummy treatment). Therefore, EMA has recommended that the product information for semaglutide medicines be updated to include NAION as a side effect with a frequency of 'very rare.' In December, a study conducted in Denmark and Norway revealed a potential link between the use of semaglutide for type 2 diabetes and an increased risk of non-arteritic anterior ischemic optic neuropathy (NAION). Additionally, New research suggests that GLP-1 receptor agonists, widely prescribed for diabetes and weight loss, may significantly raise the risk of age-related macular degeneration in older diabetic patients. A study published on Thursday in JAMA Ophthalmology by the University of Toronto researchers warns of a potential downside: increased risk of neovascular age-related macular degeneration (nAMD) in diabetic users. nAMD is a severe form of age-related macular degeneration characterized by the growth of abnormal blood vessels in the back of the eye. Analyzing medical data from over 1 million Ontario residents with diabetes, researchers identified 46,334 patients prescribed GLP-1 RAs, most of whom were taking semaglutide—likely Ozempic, since Wegovy was only recently approved in Canada. Patients on these medications were matched with participants not on GLP-1 RAs, sharing similar demographics and health profiles, and tracked for three years. The study found that diabetic patients taking GLP-1 RAs for at least six months had double the risk of developing neovascular AMD compared to non-users. Over a mean follow-up period of 2.4 years, 0.2% of the GLP-1 RA cohort progressed to nAMD compared with only 0.1% of control participants, resulting in an increased hazard for nAMD of 2.21 for the GLP-1 RA cohort. The risk was also highest in those with the longest duration of exposure. The Guardian report added that those on the medications for more than 30 months had over three times the risk. The risk was even greater in older patients and those with a prior stroke. Recent findings from the 2025 American Clinical Society of Oncology annual conference suggested that patients using weight loss drugs, including Ozempic, were about 33% more likely to be diagnosed with kidney cancer compared to matched individuals not using the medication. Price Action: NVO stock is up 2.45% at $74.43 at the last check Friday. Read Next:Photo by Tobias Arhelger via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? NOVO NORDISK (NVO): Free Stock Analysis Report This article Novo Nordisk's Wegovy Tied To Increased Risk Of Rare Vision-Loss Disorder, European Regulators Say originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
Yahoo
28-03-2025
- Health
- Yahoo
The 6 Best Canned Foods to Reduce Your Risk of Stroke, According to Dietitians
Reviewed by Dietitian Karen Ansel, M.S., RDN"Key Takeaways" A stroke is when there is a lack of blood flow or sudden bleeding in the brain. Nutrients like fiber, antioxidants, omega-3 fats and potassium may be protective. You can get these nutrients from canned beans, fish, tomatoes, beets and arteries carry oxygen-rich blood and nutrients to our brain, ensuring it has everything it needs to function optimally. However, each year, 795,000 people in the United States experience a stroke, blocking these vital blood vessels. Strokes can occur in one of two ways. The first, known as an ischemic stroke, is when a blood clot prevents blood flow to the brain. The other, called a hemorrhagic stroke, happens when a blood vessel bursts, causing bleeding in the brain. Certain health conditions like high blood pressure, diabetes, high cholesterol and atrial fibrillation can increase the chances of a stroke. However, there are steps you can take to reduce that risk. One of the most important is eating a heart-healthy diet, as cardiovascular health promotes blood flow to the brain. If that sounds complicated, you'll be happy to know there are dietitian-approved shortcuts that can help. And one of those shortcuts is leaning on certain canned foods. That said, the canned food aisle is a big place! So, we asked dietitians to share their favorite canned foods to protect against stroke. Here are their top choices to give your brain the protection it deserves. Canned beans are much more than a pantry staple. They are also a simple way to support your artery health and reduce your risk of stroke. 'Beans are an excellent source of fiber, particularly soluble fiber, which slows digestion and binds to cholesterol, pulling it out of the body,' says Lizzy Swick, M.S., RDN, a registered dietitian specializing in women's health and founder of Lizzy Swick Nutrition. This process lowers stroke risk by keeping arteries clear of plaque buildup and promoting healthier blood flow to the brain. Swick adds that canned beans are also rich in other nutrients that support cardiovascular health. This impressive nutrient profile may reduce several risk factors for cardiovascular disease and stroke, including high blood pressure, inflammation and increased blood clotting, says Swick. In addition to boasting protective antioxidants called polyphenols, beans are loaded with folate, which has been found to protect against stroke., If that weren't enough, they are also an excellent source of potassium, a key mineral for healthy blood pressure. Whether you enjoy black beans, kidney beans, white beans or chickpeas, you can reap these benefits by adding canned beans to our highly rated Sweet Potato-Black Bean Tacos or this savory Kale & White Bean Potpie. To keep sodium to a minimum, look for no-sodium-added or low-sodium canned beans. If that's not possible, rinsing canned beans before cooking can wash away about 40% of their sodium. Related: I'm a Dietitian & These Are the Reasons Why I Love Canned Beans Canned fish is loaded with nutrients that support heart health and protect your brain from stroke. From salmon and sardines to anchovies, herring and mackerel, these fish are all packed with beneficial long-chain omega-3 fatty acids. These important fats, found mainly in fatty fish, guard against stroke by lowering blood pressure and triglycerides and decreasing the likelihood of blood clots. 'Studies have shown that eating fish even twice per week can reduce the risk of stroke and heart disease,' says Skylar Griggs, M.S., RDN, LDN, a registered dietitian and CEO of Newbury Street Nutrition. Though it may be tempting to toss out the oil from your canned fish, don't! Griggs explains that the oil is also rich in brain-friendly omega-3 fatty acids. So, instead of discarding the oil, add it, along with the fish, to our 15-minute Salmon-Stuffed Avocados or a crunchy Greek Salad with Sardines. Related: 5 Reasons You Should Eat More Canned Fish, According to a Dietitian With their distinctively rich and briny flavor, canned artichokes are a great option to keep on hand to guard against stroke. 'Artichokes are a staple in the heart-healthy Mediterranean diet, celebrated for being nutrient-dense and a great source of fiber and polyphenols,' says Swick. Plus, they have anti-inflammatory and cholesterol-lowering properties, making them the perfect addition to a diet focused on reducing stroke risk, she says. That's not all. 'Artichokes are also an excellent source of potassium, which helps keep blood pressure down,' says Griggs. She recommends chopping them and adding them to sandwiches like our Spinach-&-Artichoke-Dip Grilled Cheese. They're also delicious in chicken dishes, like this Antipasto Baked Smothered Chicken. Often used as a base for sauces, soups and stews, canned tomatoes contain beneficial nutrients that help keep your brain and arteries in tip-top shape. In fact, research has found that tomato-rich diets may help lower triglycerides, oxidative stress and inflammation, all of which play a role in stroke prevention. In addition to their ample potassium, tomatoes are one of the top sources of lycopene, a powerful antioxidant linked to superior cardiovascular health (it also happens to give tomatoes their vibrant red color). Because lycopene requires fat for absorption, pair your canned tomatoes with a little heart-healthy fat, like olive oil, for maximum benefit. Canned tomatoes have another nice benefit. Because you don't have to wait for them to ripen or come into season, they're always at the peak of flavor. So, stock up and put them to work in an Easy Chicken Enchilada Casserole or our Chickpea Dumplings in Curried Tomato Sauce for delicious, satisfying weeknight dinners. Related: I'm a Dietitian & These Are My Favorite Budget-Friendly Recipes Using Canned Tomatoes When it comes to protecting brain arteries from blockages, dark leafy greens like spinach are a top choice. They're rich in magnesium, potassium and antioxidants, all of which help keep arteries clear, lower blood pressure and support healthy blood flow. In fact, research reveals that people who eat more spinach and other dark, leafy green vegetables have a lower risk of stroke. Spinach also supplies lutein, a yellow-pigmented antioxidant that contributes to stroke prevention. Like lycopene, lutein is fat-soluble, so make sure to pair it with a little healthy fat. As much as we love fresh spinach, we don't have to tell you that it doesn't last long in the crisper. Canned spinach, on the other hand, has a nice, long shelf life. Next time you head to the grocery store, grab a can to swap into this Creamy Garlic Skillet with Spinach or our Creamy Spinach-Artichoke Salmon for a flavorful, nutrient-rich meal. It's hard to beat the artery-supportive benefits of beets. These vibrant root vegetables are filled with natural nitrates, compounds the body converts into nitric oxide, which helps relax and widen blood vessel walls. This process helps reduce blood pressure and increases oxygen and nutrient transport to organs, including the brain. Nitrates are so powerful that research has found that people who consume nitrates regularly may be 17% less likely to experience an ischemic stroke. Compared to cooking and peeling fresh beets, canned beets are a huge time-saver. Sub them in for fresh beets in this tangy Beet Salad with Feta & Dill. Or, pop open a can and try them in our meat-free Pickled Beet, Arugula & Herbed Goat Cheese Sandwich. When it comes to stroke prevention, canned foods may not be the first foods that come to mind. But certain canned foods—like canned beans, fish, artichokes, tomatoes, spinach and beets—are filled with nutrients that may protect against stroke. According to dietitians, these canned gems provide antioxidants, omega-3 fatty acids, potassium, folate and fiber that can support normal blood flow and keep your brain operating smoothly. Because they're shelf-stable, they make getting the nutrients you need to support cardiovascular, blood vessel and brain health easy. For the biggest benefit, be sure to choose canned varieties with no salt or sugar added. Then, load up your shopping cart. Because a few small changes in your cupboard can make a big difference for your brain and cardiovascular health. Read the original article on EATINGWELL
