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Foldax Announces Positive One-Year Data on TRIA Mitral Valve
Foldax Announces Positive One-Year Data on TRIA Mitral Valve

Yahoo

timea day ago

  • Health
  • Yahoo

Foldax Announces Positive One-Year Data on TRIA Mitral Valve

Clinical Trial Results Presented at New York Valves and Concurrently Published in Journal of the American College of Cardiology (JACC) SALT LAKE CITY, June 27, 2025--(BUSINESS WIRE)--Foldax® Inc., a leader in the development of innovative polymer heart valves, today announced compelling one-year results from the India Clinical Trial of the TRIA™ Mitral Valve, showing a good safety profile, sustained hemodynamic performance, and statistically significant improvement in patient quality of life. These are the first one-year outcomes ever presented for a multicenter clinical study of a polymer heart valve worldwide. Results were presented today at New York Valves 2025, the annual conference organized by the Cardiovascular Research Foundation (CRF), and concurrently published in the Journal of the American College of Cardiology (JACC). Key one-year results from the trial showed: No valve-related mortality or reinterventions >50% reduction in mean gradient (9.7 mmHg to 4.5 mmHg) and >90% increase in effective orifice area (0.9 cm² to 1.5 cm²), the highest reported in similar surgical mitral valve studies 24-point improvement in KCCQ score (57.5 to 81.9) and 65% increase in Six-Minute Walk Test distance (298.1 m to 494.8 m), indicating significant improvement in quality of life The prospective, multicenter trial enrolled 67 patients aged 19 to 67 across eight sites in India, with an average age of 42. Notably, 64% were women, and of these, nearly half were of childbearing age, a significantly larger percentage than typically seen in clinical studies. Seventy-three percent of patients had rheumatic heart disease. "It is exciting to see the positive clinical outcomes associated with this novel polymer valve," said Isaac George, M.D., Surgical Director of the Heart Valve Center at Columbia University. "This new type of valve sets out to reimagine how a device can address clinical needs that are underserved by current valve solutions." "I am proud to be the principal investigator in India for this groundbreaking trial and represent the highly esteemed clinical investigators who participated in the study," said Kaushal Pandey, M.D., Principal Investigator of the TRIA Mitral Valve India Clinical Trial and Cardiac Surgeon at P.D. Hinduja Hospital in Mumbai. "The TRIA Mitral Valve provides hope for Indian patients—including younger patients and many women of childbearing age—for whom current valve options often fall short." Foldax's vision for its novel polymer heart valves is to address the limitations of tissue and mechanical options by making its valves durable, with the future goal of avoiding a requirement for lifelong anticoagulation. TRIA valves incorporate a proprietary polymer—LifePolymer™ —formulated to be calcium-resistant, biostable and biocompatible. The novel polymer material enables TRIA valves to be robotically produced, which is designed to increase manufacturing efficiency and maximize product quality and precision. "These results validate our strategy of taking heart valve therapy to a new level by bringing innovation to a platform of products that will help patients globally," said Ken Charhut, CEO of Foldax. The Journal of the American College of Cardiology (JACC) publication can be viewed at: *The TRIA Mitral Valve is approved for use in India by CDSCO. The TRIA Mitral Valve is for investigational use only and is not available for commercial sale in the U.S. About Foldax Headquartered in Salt Lake City, Utah, Foldax is reinventing every aspect of the heart valve—from material to design to manufacturing—to develop surgical and transcatheter valves with the potential to last a lifetime, addressing limitations of tissue and mechanical valves. Foldax investors include Angel Physicians Fund, Biostar Capital, Caltech, Glenview Capital, Kairos Ventures, Memorial Care Innovation Fund and Sayan Bioventures. For more information on the TRIA Mitral Valve and Foldax's commitment to revolutionizing heart valve care, visit View source version on Contacts MEDIA CONTACT: Michelle McAdam, Chronic Communications, (310) 902-1274

Who needs more exercise: Women or men?
Who needs more exercise: Women or men?

Business Mayor

time17-05-2025

  • Health
  • Business Mayor

Who needs more exercise: Women or men?

Exercising regularly is known to lower the risk of death, especially from heart problems. But scientists have discovered that that reduction in risk may differ between the sexes, with some people reaping greater benefits in less workout time. So, who has to exercise more to reduce their risk of death: Women or men? It turns out that women may reap these survival benefits more easily than men do. That's according to a large study published in 2024 in the Journal of the American College of Cardiology , which included data from more than 412,000 American adults ages 27 to 61, 55% of whom were female. You may like 'The beauty of this study is learning that women can get more out of each minute of moderate to vigorous activity than men do,' study co-lead author Dr. Martha Gulati , director of preventive cardiology in the Smidt Heart Institute at Cedars-Sinai, said in a statement . 'It's an incentivizing notion that we hope women will take to heart.' The researchers collected participants' physical activity data via the National Health Interview Survey (NHIS), the largest and longest-running health survey in the U.S. The study looked at data collected between 1997 and 2017. Related: 11 minutes of moderate exercise a day cuts early death risk by 20%, huge analysis suggests The survey itself included questions about the types of exercises people performed and at what frequencies, durations and intensities. It also included participants' socioeconomic and demographic characteristics and medical conditions. The study excluded people who had certain health conditions at the start of the study time frame, such as coronary heart disease or cancer. Read More Most melatonin gummies have higher doses than what's on the label Get the world's most fascinating discoveries delivered straight to your inbox. The researchers also looked through the National Death Index — a national database of death records — for deaths from any cause, as well as cardiovascular-related deaths. The data from survey participants is linked to this death-record data , so the researchers could then connect the data from their NHIS participants to the mortality data through the end of 2019. Overall, 39,935 participants died in the study timeframe, including 11,670 cardiovascular-related deaths, such as those from heart disease, heart attacks and strokes. About 32% of the women and 43% of the men surveyed said they engaged in regular aerobic exercise , exercising for at least 150 minutes per week. Compared to inactive individuals of the same sex, women who exercised regularly had up to a 24% lower risk of death from any cause. For men who exercised regularly, however, the reduction in mortality risk reached only 15%. Women also gained these survival benefits much more quickly than men did, the study found. In men, the highest reduction in death risk was seen at about 300 minutes of moderate-to-vigorous physical activity (MVPA) per week. That came with an 18% reduction in all-cause mortality. Women saw an equal benefit in less than half that time, at about 140 minutes of MVPA a week. Women who trained more than that each week saw a greater benefit until they also peaked at around 300 minutes of weekly MVPA. That trend held true across all durations of exercise, the researchers found, with women consistently seeing 'proportionately greater benefits' for any amount of exercise than men did. About 20% of women and 28% of men said they engaged in two or more sessions of strength training, such as lifting weights, each week. Overall, though, women reported an average of about 0.85 sessions per week, while men averaged 1.25 sessions per week. On average, the women who strength-trained at least twice a week had a 19% lower mortality risk than women who trained less often or not at all. Men, on average, saw a 11% lower risk compared with inactive men. These benefits were even greater when it came to cardiovascular health specifically. Related: Why is it harder for some people to build muscle than others? Compared with inactive individuals, women who performed aerobic physical activity had a 36% lower cardiovascular mortality risk, while for active men, this risk reduction was about 14%. Muscle strengthening produced similar outcomes, with a cardiovascular risk reduction of 30% for women and 11% for men, compared to baseline. 'What surprised us the most was the fact that women who do muscle strengthening had a reduction in their cardiovascular mortality by 30%,' Gulati told NPR . 'We don't have many things that reduce mortality in that way,' she added. The study did have some limitations, including that people's exercise data was self-reported, so it relied on the participants accurately reporting their activity study also tracked only leisure-time exercise, meaning it didn't count exercise completed during household tasks or as part of a job, which may have also contributed to the results. In addition, the study didn't account for potentially unassessed health issues in some participants, or changes in people's exercise trends over time. That said, the results echo similar findings from a 2011 meta-analysis published in the journal Circulation . This review of 33 studies concluded that there was a stronger link between exercise and lower death risk in women than men. The researchers behind the 2024 study hope their findings could help motivate more women to exercise, whether through traditional ' cardio ' or muscle strengthening regimes including bodyweight exercises or lifting weights. 'I am hopeful that this pioneering research will motivate women who are not currently engaged in regular physical activity to understand that they are in a position to gain tremendous benefit for each increment of regular exercise they are able to invest in their longer-term health,' Dr. Christine Albert , chair of the Department of Cardiology in the Smidt Heart Institute who was not involved in the study, said in the statement.

Anti-inflammatory spice that could help lower cholesterol levels
Anti-inflammatory spice that could help lower cholesterol levels

Daily Record

time30-04-2025

  • Health
  • Daily Record

Anti-inflammatory spice that could help lower cholesterol levels

Recent studies have shown that a well-loved spice could be the key to reducing cholesterol and even fighting cancer. This particular fruit is packed with a compound renowned for its multitude of health benefits. Chilli peppers are emerging as a potential ally for heart health and more, due to capsaicin, the fiery component that gives chillies their heat, reports the Express. Not only does capsaicin bring the spice to chillies, but it also has properties that may lower cholesterol and help in the fight against cancer and arthritis. A 2022 study published in the Frontiers in Nutrition journal highlighted capsaicin's effects on cholesterol levels. This research involved an analysis of nine controlled trials with 461 patients suffering from metabolic syndrome—a combination of health issues that heighten the risk of type 2 diabetes, heart disease, and stroke. The results showed that capsaicin significantly reduced total cholesterol and low-density lipoprotein cholesterol, commonly known as "bad" cholesterol. The study's authors stated: "Capsaicin (CAP) supplementation is a promising approach to decreasing total cholesterol and low-density lipoprotein cholesterol levels in patients with metabolic syndrome. However, short-term (less than 12 weeks) use of CAP in women may also reduce triglycerides [a type of fat found in the blood] levels." Other studies have suggested that chillies and their fiery compound capsaicin might be useful in combating heart disease. A standout piece of research published in the Journal of the American College of Cardiology from 2019 highlighted a connection between regular chilli consumption and a decreased risk of heart disease mortality. The study scrutinised the eating habits and health records of over 22,000 individuals living in Southern Italy, with an average follow-up period just over eight years. The results were quite remarkable: individuals who ate chilli peppers more than four times per week appeared to have about one-third reduction in death risk from heart disease compared to those who avoided these piquant pods. Intriguingly, this benefit seemed to hold true regardless of whether participants adhered to a Mediterranean diet or consumed less healthy diets. The researchers concluded: "In a large adult Mediterranean population, regular consumption of chilli pepper is associated with a lower risk of total and cardiovascular disease (CVD) death independent of CVD risk factors or adherence to a Mediterranean diet. Known biomarkers of CVD risk only marginally mediate the association of chilli pepper intake with mortality." Adding to the wealth of knowledge, a 2021 study published in the Angiology journal brought together data from four separate studies examining the intake of spicy food – specifically chilli peppers, chilli sauce, or chilli oil – and its connection to cardiovascular disease. This collective research, involving 564,748 participants over an average period of 9.7 years, uncovered an intriguing association between regular consumption of spicy food and health advantages. Researchers identified that individuals who frequently enjoy spicy foods have a lower mortality risk overall, as well as reduced death rates from cardiovascular diseases. Their findings revealed: "The pooled data suggested that compared with people who did not regularly consume spicy food, regular consumers of spicy food experienced a 12% lower risk of all-cause mortality." Moreover, they noticed that eating spicy food correlates significantly with a decreased risk of death from heart disease but found no similar link regarding cerebrovascular conditions. In their conclusion, the researchers indicated: "Available epidemiological studies suggest that the consumption of spicy chilli food is associated with reduced risk of all-cause as well as heart disease-related mortality. Further studies in different populations are needed to confirm this association." In a study featured in the 2022 edition of the Molecules journal, it was suggested that capsaicin could play a crucial role in warding off obesity. The research also pointed out its anti-inflammatory and anti-cancer qualities. The scientists involved noted: "Capsaicinoids act against high cholesterol levels and obesity, show anticancer effects, and are used to treat arthritis pain."

Study finds a better way to detect heart disease in women
Study finds a better way to detect heart disease in women

Time of India

time27-04-2025

  • Health
  • Time of India

Study finds a better way to detect heart disease in women

Although heart diseases might widely be known as 'man's disease', recent research has revealed that heart-related diseases are the leading cause of death in women. While men may be at higher risk for heart disease and heart attacks at a younger age, heart disease is a significant health concern for both men and women. Moreover, while women are as likely to have a heart attack as men, they are more likely to die from one. In fact, cardiovascular disease (CVD), including heart attacks, globally, is responsible for 35% of all female deaths. Although the recent research might trigger a sense of panic, the better news is – a new study has emerged to show that using personalized heart wall measurements leads to more accurate hypertrophic cardiomyopathy diagnoses, especially in women. What does the study say? People with hidden heart conditions may be at risk because current medical guidelines overlook important personal differences. This new study, recently published in the Journal of the American College of Cardiology , is questioning an outdated standard for diagnosing heart disease that often goes unnoticed until it is too late. Hypertrophic cardiomyopathy (HCM) affects about one in every 500 people. It can lead to dangerous heart rhythms, sudden cardiac arrest, and even death. This genetic condition thickens the heart muscle, making it harder for the heart to pump blood. For years, doctors diagnosed HCM based on one measurement: if the left ventricle wall is 15 millimeters thick or more, it is considered abnormal. While this method has saved lives, scientists are now highlighting its flaws. A recent study shows that this fixed threshold may leave many people undiagnosed, particularly women and smaller individuals. How current guidelines leave gaps: HCM is usually diagnosed by measuring the thickness of the wall in the heart's main pumping chamber. For 50 years, the guideline has remained the same: a wall thicker than 15 millimeters may indicate HCM. This cutoff does not change based on age, sex, or body size, which is a problem. Not all hearts are the same size. Women typically have smaller hearts, so a thickened wall in a smaller heart might not reach the 15-millimeter mark, even if the person has HCM. Men, who generally have larger hearts, might meet the threshold even if they do not have the disease. Data supports this concern. Currently, two out of three people diagnosed with HCM are men. However, researchers believe that men and women are equally likely to have the disease, and women may be overlooked by an outdated system. Dr. Hunain Shiwani, who led the study at the UCL Institute of Cardiovascular Science, said, 'This threshold, based on studies from the 1970s, needs to be reconsidered. Using the same cutoff for everyone, regardless of age, sex, or size, ignores how these factors strongly influence heart wall thickness.' Personalized method to ensure better accuracy: To address this issue, researchers developed a smarter, more individual approach. They used artificial intelligence to study over 5,000 MRI heart scans from healthy individuals. The AI measured heart wall thickness in people of different ages, sexes, and body sizes. From this, they created a range of normal values that reflect actual differences in heart structure. Instead of a single number, the new method adjusts the threshold based on a person's profile. For example, older or larger people might have a higher cutoff, while younger, smaller people, including many women, would have a lower one. When researchers tested this updated method on 1,600 patients already diagnosed with HCM, they saw significant improvements. Among women, detection rates increased by 20 percentage points. This means that one in five women who would have been missed before are now recognized as having the disease. Dr. Shiwani added, 'Our research provides a much-needed update, showing that a personalized approach improves diagnosis accuracy. Effective treatments for HCM are starting to be used for the first time, making it crucial to correctly identify those who need them.' The new guidelines: Researchers applied new and old methods to check for hypertrophic cardiomyopathy (HCM) in over 43,000 people from a health database. Using the old method, only one in eight people flagged as possibly having HCM was a woman. The flagged individuals were usually older, taller, and heavier than average. With the new personalized approach, the number of flagged cases actually decreased, which means fewer false positives. Importantly, nearly half of those identified (44%) were women, which aligns better with the fact that HCM affects both men and women equally. The goal is not only to find more cases but also to avoid mistakes. A wrong diagnosis can change someone's life by leading to unnecessary tests, anxiety, or medication. Dr. Sonya Babu-Narayan from the British Heart Foundation highlighted the importance of preventing misdiagnoses. She said, 'A diagnosis changes lives, so we should work hard to avoid misdiagnosing people.' By updating the old approach, this study redefines what is considered abnormal heart wall thickness, a key factor in diagnosing HCM. This change helps identify more women and smaller individuals who might otherwise be overlooked. The way forward: The research findings are available online in the Journal of the American College of Cardiology. This research could greatly change how doctors identify and treat HCM worldwide. The scientists want to ensure that the new guidelines also work with echocardiograms, as these are more commonly used in clinics than MRIs. They are also exploring ways to include other important factors, such as race and ethnicity, in future diagnostic tools. The aim is to help doctors make better decisions for every patient, regardless of their shape or size. The research team hopes that heart specialists in Europe and North America will adopt these updated guidelines soon. Personalized thresholds could become standard, leading to fairer and more accurate diagnoses. Dr. Babu-Narayan concluded, 'This more personalized approach to defining abnormal heart muscle thickness marks a new era for accurate diagnosis for patients and families affected by hypertrophic cardiomyopathy.' Study finds how female, male hearts respond differently to stress hormone

Heart Attack Risk May Drop For Millions With Wonder Drug That Reduces Cholesterol By 94%
Heart Attack Risk May Drop For Millions With Wonder Drug That Reduces Cholesterol By 94%

News18

time23-04-2025

  • Health
  • News18

Heart Attack Risk May Drop For Millions With Wonder Drug That Reduces Cholesterol By 94%

Last Updated: A US pharma company has developed an experimental drug that reduces lipoprotein(a) cholesterol by 94% with a single injection, offering new hope for heart attack prevention. A revolutionary breakthrough in cardiovascular medicine has emerged from the United States, offering new hope for millions at risk of heart attacks due to stubborn cholesterol buildup. US pharmaceutical giant Eli Lilly has developed an experimental drug that reportedly slashes levels of a notoriously difficult form of cholesterol by an astonishing 94% – with a single injection. The drug targets lipoprotein(a), or Lp(a), a genetic variant of cholesterol that behaves similarly to the more familiar LDL, often dubbed 'bad cholesterol." However, Lp(a) is markedly more dangerous. It adheres rapidly to arterial walls, accelerating the onset of atherosclerosis – the hardening and narrowing of arteries – and significantly increasing the risk of heart attack and stroke. Unlike LDL, which can often be managed through diet, lifestyle, and existing medications, Lp(a) has long resisted conventional treatment. In a phase 2 clinical trial conducted by Eli Lilly, 141 participants received a 400 mg dose of the investigational drug. Another 69 individuals were administered a placebo. The results, published in the Journal of the American College of Cardiology, presented that within weeks, recipients of the drug showed a dramatic 94% reduction in Lp(a) levels, an effect that lasted up to six months with no reported side effects. 'This is a very promising development," said Dr Nitish Chandra, Principal Director at Fortis Escorts Heart Institute in Delhi. Until now, no therapy has effectively targeted Lp(a). Even blood-thinning medications can't remove this cholesterol from arteries and because Lp(a) is largely inherited, patients often face lifelong risk without any means of intervention, he said. Currently, individuals with severe cholesterol blockage – more than 75% arterial narrowing – typically require a stent implantation to reduce the threat of a cardiac event. Conventional medications fail to dissolve cholesterol once it has significantly accumulated in the arteries, making prevention and early detection the primary strategies for at-risk patients. That may now change. The Eli Lilly trial is only the beginning. While the reduction in Lp(a) is clear, whether it translates into fewer heart attacks or strokes remains to be proven. A larger, more comprehensive clinical trial is already underway, aiming to determine the drug's impact on long-term cardiovascular outcomes. Results from that trial are expected soon. Meanwhile, Swiss pharmaceutical company Novartis is also in the race, developing a competing drug that requires monthly injections. Both treatments could potentially reshape the landscape of cardiac care, particularly for individuals with genetically elevated cholesterol who have, until now, had limited options. First Published:

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