Latest news with #AnnualScientificSession&Expo
Yahoo
31-03-2025
- Health
- Yahoo
GE HealthCare's Latest Product Launch to Boost Cardiology Care
GE HealthCare Technologies Inc. GEHC recently announced the U.S. launch of Flyrcado (flurpiridaz F 18) injection at the ongoing American College of Cardiology (ACC) Annual Scientific Session & Expo. It also plans to unveil the latest version of CASE (Cardiac Assessment System for Stress Testing), powered by its CardioSoft technology, at the ACC. GE HealthCare also plans to showcase CardIQ Suite (an integrated workflow for the seamless review of calcium scoring and cardiac computed tomography angiography data) and its recently launched AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab editions. GEHC aims to highlight its strategy to leverage AI to help increase efficiency and enable seamless integration of data across the cardiology care pathway by showcasing its latest AI-powered innovations. The latest launch is expected to significantly strengthen GE HealthCare's Cardiology Solutions unit, thus boosting its overall business. Per GE HealthCare's estimates, around six million myocardial perfusion imaging (MPI) procedures are undertaken each year in the United States to show blood flow through the heart muscle and evaluate the presence, extent and degree of myocardial ischemia or infarction. Positron emission tomography (PET) is currently the most effective form of MPI for detecting coronary artery disease (CAD) and is recommended for a wide range of patients, including those considered more challenging to diagnose, over single-photon emission computed tomography (SPECT) MPI. GEHC further stated that the FDA approved Flyrcado for patients with known or suspected CAD in 2024. This is expected to deliver higher diagnostic efficacy, unlike SPECT MPI, the predominant procedure used in nuclear cardiology at present. GE HealthCare's management believes that the launch of Flyrcado represents a significant advancement in cardiac care, providing a new, highly effective diagnostic tool for those with known or suspected CAD. Additionally, Flyrcado has been granted traditional pass-through payment status by the U.S. Centers for Medicare and Medicaid (CMS). The receipt of pass-through status from the CMS, effective April 1, secures a drug-specific Healthcare Common Procedure Coding System or HCPCS billing code and coverage for traditional Medicare beneficiaries. Pass-through payment status will likely enable CMS to provide separate payments for radiopharmaceutical and PET-CT scan, when performed with Flyrcado in the hospital outpatient setting. Per a report by Grand View Research, the global coronary heart disease diagnostic imaging device market was estimated to be $2 billion in 2024 and is anticipated to witness a CAGR of 6.6% between 2025 and 2030. Factors like the increasing prevalence of CAD and the rising adoption of early diagnostic techniques are likely to drive the market. Given the market potential, the latest product availability is expected to provide a significant boost to GE HealthCare's business. This month, GEHC announced the launch of the AltiX AI.i edition of Mac-Lab, CardioLab and ComboLab. The AltiX AI.i edition is expected to enhance efficiency and precision care for multiple types of cardiac procedures. GEHC's peer in the cardiovascular space, Merit Medical Systems, Inc. MMSI, announced the enrollment of the first patient in its multicenter, prospective study of the Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in premature infants (PREEMIE study) this month. Per Merit Medical, the Bloom Micro Occluder System was designed as a minimally invasive option for treating hemodynamically significant PDA. The PREEMIE study has been developed to evaluate its safety and efficacy. Last month, Merit Medical reported its fourth-quarter 2024 results, wherein its Cardiovascular unit and all its product categories reported robust revenue growth. Another player and GE HealthCare's peer in the cardiovascular space is Medtronic plc MDT. This month, Medtronic released the two-year positive results of the Small Annuli Randomized To Evolut or SAPIEN (SMART) Trial, the largest international head-to-head comparative trial of transfemoral transcatheter aortic valve replacement. Last month, Medtronic reported its third-quarter fiscal 2025 results, wherein its Cardiovascular Portfolio witnessed a robust revenue uptick on both reported and organic basis. Another renowned peer in the cardiovascular space is Abbott Laboratories ABT. This month, ABT announced the receipt of the CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation. Following this, Abbott has begun commercial PFA cases in the European Union (EU) with physicians who are familiar with the Volt PFA System within its PFA clinical studies. ABT plans to further expand the use of Volt in EU markets throughout the second half of the year. Abbott also announced this month that the FDA has approved an investigational device exemption for its Coronary Intravascular Lithotripsy System to evaluate the treatment of severe calcification in coronary arteries prior to stenting. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Abbott Laboratories (ABT) : Free Stock Analysis Report Medtronic PLC (MDT) : Free Stock Analysis Report Merit Medical Systems, Inc. (MMSI) : Free Stock Analysis Report GE HealthCare Technologies Inc. (GEHC) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
Yahoo
31-03-2025
- Health
- Yahoo
New Data Confirm Rapid, Unpredictable Progression of Severe Aortic Stenosis and Need for Urgent Referral and Evaluation of Patients
CHICAGO, March 31, 2025--(BUSINESS WIRE)--Edwards Lifesciences (NYSE: EW) today announced new scientific evidence presented and published during the American College of Cardiology's (ACC) Annual Scientific Session & Expo, addressing the critical needs of patients with structural heart disease. Without treatment, 1 in 10 patients experiencing symptoms of severe aortic stenosis (AS) may die within five weeks. However, the symptoms of severe AS can be difficult to detect and may progress rapidly and unpredictably. New data presented at ACC underscore the importance of urgently referring patients to a heart team for evaluation once diagnosed. Among the groundbreaking data were findings from the randomized, controlled DETECT AS study, the first to evaluate the impact of automatic electronic provider notifications (echo alerts) for patients with severe AS. In this trial involving 939 patients and 285 physicians, those who ordered an echo for severe AS were randomized to either receive an echo alert describing treatment guidelines or no notification. The findings revealed echo alerts increased aortic valve replacement (AVR) treatment rates by 11 percent for all patients with severe AS, and 14 percent for symptomatic severe AS patients. Echo alerts also significantly improved AVR treatment rates among older patients and women, thereby reducing age and gender disparities. The results were simultaneously published in Circulation. "These data illuminate the persistent under-referral and under-treatment of severe AS patients and the significant impact a critical echo notification can have on improving treatment of this deadly disease," said Sammy Elmariah, M.D., Interventional Cardiology Medical Director, Cardiac Catheterization Laboratory, and associate professor at the University of California, San Francisco. Additional insights from the EARLY TAVR trial were also presented at ACC. The EARLY TAVR trial was the first randomized, controlled FDA pivotal study designed to determine the best strategy for treating asymptomatic severe AS and the benefits of timely intervention with TAVR. The data were published in The New England Journal of Medicine and demonstrated that asymptomatic severe AS patients randomized to Edwards TAVR experienced superior outcomes compared with guideline-recommended clinical surveillance (watchful waiting), with no clinical penalty for timely intervention. The new study presented at ACC evaluated outcomes of patients treated in the EARLY TAVR trial segmented by the severity of their signs and symptoms once they converted to AVR. These data reiterate that watchful waiting is not an effective strategy for the management of severe AS. In addition, it was hypothesized that cardiac biomarkers may be predictive of the best time for severe AS patients to go from watchful waiting to receiving treatment. Another new study presented at ACC showed that biomarkers were not predictive, further underscoring the rapid and unpredictable progression of the disease and urgency to refer patients to a heart team for evaluation and treatment. Results of the biomarkers study were simultaneously published in Circulation. "The data from these new studies confirm that severe aortic stenosis is a complex disease and reiterate the need for urgent referral and evaluation of treatment for patients with or without symptoms," said Larry Wood, Edwards' corporate vice president and group president, transcatheter aortic valve replacement and surgical structural heart. "We remain committed to advancing high-quality science and delivering life-saving structural heart therapies for patients with our leading SAPIEN valve platform, which has been used to treat more than 1 million patients worldwide." About Edwards Lifesciences Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most. Discover more at and follow us on LinkedIn, Facebook, Instagram and YouTube. This news release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We intend the forward-looking statements contained in this release to be covered by the safe harbor provisions of such Acts. These forward-looking statements can sometimes be identified by the use of forward-looking words, such as "may," "might," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "goal," "continue," "seek," "intend," "optimistic," "aspire," "confident" and other forms of these words and include, but are not limited to, statements made by Mr. Wood and Dr. Elmariah and statements regarding expected product benefits, including patient outcomes, objectives and expectations and other statements that are not historical facts. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made, and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. Investors are cautioned not to unduly rely on such forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause results to differ materially from those expressed or implied by the forward-looking statements based on a number of factors as detailed in the company's filings with the Securities and Exchange Commission. These filings, along with important safety information about our products, may be found at Edwards, Edwards Lifesciences, the stylized E logo, and EARLY TAVR are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners. View source version on Contacts Media Contact: Heather Bukant, 949-250-2753Investor Contact: Mark Wilterding, 949-250-6826
Yahoo
29-03-2025
- Health
- Yahoo
Imbria Presents Positive Clinical Data from Phase 2 IMPROVE-DiCE Trial of Ninerafaxstat in Patients with Cardiometabolic HFpEF at ACC.25
– Ninerafaxstat improves cardiac energetics, cardiac reserve capacity, 6-minute walk distance and heartfailure-related health status (KCCQ) in cardiometabolic HFpEF – – Findings support further development of ninerafaxstat in HFpEF and adjacent CV indicationssuch as non-obstructive hypertrophic cardiomyopathy (nHCM) – BOSTON, March 29, 2025 (GLOBE NEWSWIRE) -- Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to enhance cellular energetics, today announced positive clinical results from Part 2 of the IMPROVE-DiCE Phase 2 trial demonstrating that ninerafaxstat improved cardiac energetics, left ventricular reserve capacity, exercise capacity and patient-reported heart failure symptoms and physical limitations in patients with cardiometabolic heart failure with preserved ejection fraction (HFpEF). The results were presented at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25) in Chicago, IL during the moderated poster session titled 'Innovations and Insights in Heart Failure With Preserved Ejection Fraction: Emerging Therapies, Biomarkers and Mechanistic Studies.' 'These findings validate the mechanistic rationale for targeting impaired myocardial energetics in HFpEF and demonstrate ninerafaxstat's potential to restore resting cardiac energetics and enhance functional cardiac reserve,' said Oliver Rider, MRCP(UK), DPhil (Oxon), Professor of Cardiovascular Medicine, University of Oxford. 'Importantly, these results suggest ninerafaxstat could improve daily symptoms and physical capacity for people living with HFpEF, a condition with few effective treatments available today.' Key findings from the trial include: Treatment of patients with cardiometabolic HFpEF with ninerafaxstat for 12 weeks resulted in a statistically significant (P=0.02) increase from baseline in cardiac phosphocreatine to adenosine triphosphate (PCr/ATP) ratio, consistent with an improvement in cardiac energy reserves and meeting the trial's primary objective. Of note, the largest energetic responses to ninerafaxstat were observed in those with the most severe energy deficit at baseline. Significant improvement in left ventricular (LV) systolic reserve capacity with exercise, reflecting an increase in the heart's ability to augment its stroke volume during exercise (P=0.03), a key abnormality in patients with HFpEF. Consistent with enhanced LV reserve capacity, an increase in 6-minute walk distance of ~14 m (P=0.02) was observed. Statistically significant and clinically meaningful improvements in heart failure-related health status, measured by the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS), were observed in patients most symptomatically limited at baseline, pre-specified as those with KCCQ-CSS ≤80 (~8 points; P=0.04). 'Approximately 50% of heart failure cases are related to HFpEF. In the U.S. alone, the prevalence is expected to rise to 8.5 million by 2030. Within the HFpEF population, at least 80% are living with type 2 diabetes mellitus (T2DM) and obesity. There are no current treatments aimed at targeting mitochondrial energy generation to improve patient symptoms, quality of life, and functional capacity. We believe these validating results pave the way to support further investigation of ninerafaxstat in cardiometabolic HFpEF,' said Jai Patel, MRCP(UK), Chief Medical Officer at Imbria. 'Ninerafaxstat's unique therapeutic profile has the potential to make a meaningful impact in cardiometabolic HFpEF and pathophysiologically adjacent disease states such as nHCM.' A copy of the poster will be available in the 'Media Center' section of the Imbria website at About ninerafaxstatNinerafaxstat is an innovative treatment for cardiac disorders characterized by an imbalance of energy supply and demand in the heart. To maintain normal contractile function, the heart requires substantial amounts of energy, which is produced primarily by the mitochondria in the form of adenosine triphosphate (ATP). The heart normally uses two main fuels for energy generation: fatty acids and glucose. Ninerafaxstat, a partial fatty acid oxidation (pFOX) inhibitor, acts to shift the heart's preference from fatty acids towards glucose. This shift in metabolism leads to more efficient mitochondrial energy generation with the potential for improved cardiac function both at rest and during exercise. Ninerafaxstat is a simple orally administered compound with no dose titration or monitoring required, no clinically significant drug-drug interactions and can be used on top of standard of care cardiovascular treatments. About IMPROVE-DiCEIMPROVE-DiCE is the first clinical trial utilizing multi-nuclear spectroscopy, including state-of-the-art hyperpolarized MR spectroscopy, and MRI to quantify the cardiac energetic, metabolic and functional responses to an investigational metabolic modulator in cardiovascular disease. It is a two-part, Phase 2 clinical trial evaluating the safety, tolerability and pharmacodynamic effects of ninerafaxstat. Part 1 enrolled pre-HFpEF patients with type 2 diabetes and obesity and demonstrated normalization of cardiac energetics, significant reduction in cardiac steatosis and improvements in left ventricular diastolic filling rate, an important component of heart failure. The results of Part 1 were presented at the European Society of Cardiology Congress in August 2022. Part 2 of IMPROVE-DiCE enrolled symptomatic patients with cardiometabolic HFpEF and assessed the impact of ninerafaxstat on cardiac energetics, cardiac reserve function, exercise capacity and heart failure symptoms. The trial was conducted at the Oxford Centre for Clinical Magnetic Resonance Research (OCMR), Radcliffe Department of Medicine at the University of Oxford, UK and was led by Professor Oliver Rider. For more information, please visit (Identifier: NCT04826159). About heart failure with preserved ejection fraction (HFpEF)Over half of all patients with heart failure have preserved ejection fraction, a clinical syndrome characterized by an inability of the heart to pump blood adequately to the body without pathological increases in filling pressures at rest or during exertion. As with other forms of heart failure, HFpEF is associated with cardiac energy deficiency resulting from impaired mitochondrial energy generation. This leads to impaired cardiac functional reserve on exertion and is associated with exercise-induced pulmonary congestion, resulting in hallmark heart failure symptoms of exertional breathlessness, fatigue, and markedly reduced exercise capacity leading to severe impairment in quality of life. Despite being associated with severe morbidity and mortality, HFpEF has few evidence-based therapies. Within the clinical syndrome of HFpEF, the cardiometabolic HFpEF phenotype, in which chronic cardiometabolic stress resulting from type 2 diabetes and obesity are key drivers of heart failure pathophysiology, is rapidly emerging as the most prevalent form. About ImbriaImbria is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical pipeline is focused on restoring or improving the cell's ability to produce energy in cardiometabolic disorders where energetic impairment is a fundamental contributor to disease pathogenesis, symptoms and functional deficits. The lead product candidate, ninerafaxstat, has completed multiple Phase 2 clinical trials in three indications: nHCM, stable angina, and HFpEF. In Phase 1 and 2 clinical trials, ninerafaxstat was shown to be well tolerated. For additional information, please visit ContactKomal JoshiImbria Pharmaceuticals, in to access your portfolio
Associated Press
28-03-2025
- Health
- Associated Press
RWJBarnabas Health and Rutgers Health to Unveil Pioneering Cardiovascular Research at the American College of Cardiology's Annual Scientific Session & Expo
Research will highlight the latest advancements in cardiovascular care through 55 abstract presentations WEST ORANGE, N.J., March 28, 2025 /PRNewswire/ -- Physician-scientists from RWJBarnabas Health and Rutgers Health will showcase a comprehensive collection of innovative cardiovascular research at this year's American College of Cardiology's Annual Scientific Session & Expo (ACC.25), taking place in Chicago, IL from March 29-31, 2025. A total of 55 abstracts will be presented, featuring clinical data and analyses that advance the understanding, treatment, and prevention of cardiovascular disease. Research presented at the conference was conducted by residents and faculty in the cardiovascular service at Community Medical Center, Cooperman Barnabas Medical Center, Jersey City Medical Center, Newark Beth Israel Medical Center and Robert Wood Johnson University Hospital. RWJBarnabas Health cardiac centers of excellence are nationally recognized for patient care and superior outcomes, including being named as one of Becker's top 100 Great Heart Programs in the country and recognized by American College of Cardiology as a Proven Quality Program. Rutgers Health faculty presenting at the conference represents the Division of Cardiology and the Division of Cardiothoracic Surgery at Rutgers New Jersey Medical School, and the Division of Cardiovascular Diseases and Hypertension and the Division of Cardiothoracic Surgery at Robert Wood Johnson Medical School. 'We continue to drive advancements in cardiovascular care and enhance patient outcomes through transformative research and clinical excellence,' said Conor Barrett, MD, MBA, Senior Vice President and Chief Clinical Officer of RWJBarnabas Health Heart and Vascular Services. 'The data we are presenting at ACC.25 underscores our ongoing commitment to innovation in the prevention, diagnosis, and treatment of heart and vascular diseases. By leveraging cutting-edge science and fostering collaboration with leading experts, we are developing strategies that not only reduce cardiovascular risk but also improve the overall quality of life for patients in our communities.' RWJBarnabas Health and Rutgers Health remain at the forefront of cardiovascular innovation. Their participation at ACC.25 reinforces their ongoing commitment to advancing research, improving patient outcomes, and shaping the future of heart and vascular care. Highlights of the accepted abstracts include the following presentations: Research exploring the use of machine learning models based on cardiac ultrasound radiomics (ultrasomics) to identify myocardial infarction with high accuracy. It compares traditional handcrafted ultrasound features with deep learning-based 3D convolutional neural networks, demonstrating that ultrasomics could provide the association with CMR-driven infarct localization and myocardial tissue characterization in acute myocardial infarction patients. Highlights from a Fragility Index Analysis of the ARIES-HM3 trial, which evaluated the robustness of findings supporting an aspirin-free regimen in HeartMate III LVAD patients. The analysis confirms that the composite primary outcome (survival free of a major nonsurgical hemocompatibility-related adverse events, including stroke, pump thrombosis, major bleeding, or arterial thrombosis) remains robust with an FI of 24, driven primarily by a reduction in bleeding events, reinforcing the trial's potential practice-changing impact. Findings from the FINEARTS-HF trial which demonstrated efficacy of finerenone in the reduction of a composite endpoint of cardiovascular death and heart failure events in patients with left ventricular ejection fraction (LVEF) ≥40%. This fragility index analysis confirms that these findings are remarkably robust, with a Fragility Index (FI) of 112, primarily driven by a significant reduction in heart failure hospitalizations (F1 of 112), making it more robust than most practice-changing trials in the cardiology field. Immune checkpoint inhibitors (ICIs) are widely used in cancer treatment but can cause rare, life-threatening myocarditis. Our findings highlight that timely recognition and management of ICI-induced myocarditis are crucial to preventing severe cardiac complications. Hypertrophic obstructive cardiomyopathy (HOCM) is a complex, life-threatening disease with limited treatment options, however the approval of Mavacamten introduced a novel approach by directly targeting the disease's molecular pathology. Our findings suggest the need for further research to evaluate long-term side effects of Mavacamten. The full list of presentations at this year's ACC.25 Annual Scientific Session & Expo can be found here. About RWJBarnabas Health RWJBarnabas Health is the largest, most comprehensive academic health care system in New Jersey, with a service area covering eight counties with five million people. The system includes twelve acute care hospitals – Clara Maass Medical Center in Belleville, Community Medical Center in Toms River, Cooperman Barnabas Medical Center in Livingston, Jersey City Medical Center in Jersey City, Monmouth Medical Center in Long Branch, Monmouth Medical Center Southern Campus in Lakewood, Newark Beth Israel Medical Center in Newark, Robert Wood Johnson University Hospital in New Brunswick, Robert Wood Johnson University Hospital Somerset in Somerville, Robert Wood Johnson University Hospital Hamilton in Hamilton, Robert Wood Johnson University Hospital Rahway in Rahway and Trinitas Regional Medical Center in Elizabeth, three acute care children's hospitals, Children's Specialized Hospital with a network of outpatient pediatric rehabilitation centers, a freestanding 100-bed behavioral health center, two trauma centers, a satellite emergency department, ambulatory care centers, geriatric centers, the state's largest behavioral health network, comprehensive home care and hospice programs, fitness and wellness centers, retail pharmacy services, affiliated medical groups, multi-site imaging centers and two accountable care organizations. RWJBarnabas Health is among New Jersey's largest private employers – with more than 41,000 employees and 9,000 physicians– and routinely captures national awards for outstanding quality and safety. RWJBarnabas Health launched an affiliation with Rutgers University to create New Jersey's largest academic health care system. The collaboration aligns RWJBarnabas Health with Rutgers' education, research and clinical activities, including those at the Rutgers Cancer Institute of New Jersey - the state's only NCI-designated Comprehensive Cancer Center - and Rutgers University Behavioral Health Care. For journalists – contact: 732.507.8307
